Q4 2023 AIM ImmunoTech Inc Earnings Call
None: [music].
Hello, and welcome to the aim immuno tax fiscal year, 'twenty twenty-three update conference call and webcast.
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Forward looking statements on this call are made pursuant to the safe Harbor physicians of the federal Securities laws and are based on <unk> current expectations and actual results could differ materially.
As a result, you should not place undue reliance on any forward looking statements some.
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 aimed files with the securities and Exchange Commission fees.
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Completeness of ore that any independent sources verified any information obtained from third party sources, joining us on today's call from aimed leadership team.
Thomas equals Chief Executive Officer, and Dr. Christopher Mcaleer Scientific officer, I would now like to proceed to turn the call over to Mr. Equals. Please proceed sir.
Thomas: Thank you everyone for joining us.
Thomas: 2023 was an extremely important year frame.
Thomas: We demonstrated progress, resulting in significant advancements across our pipeline showcasing a growing body of highly promising consistent positive data with our priority development programs.
Thomas: This data driven progress.
Thomas: Drives our firm enthusiasm and belief in ampligen has long term potential.
Thomas: These many areas, where we have shown clinical therapeutic.
Thomas: Now you went through the data and.
Thomas: And these are not only unmet medical need and sometimes lethal unmet medical needs, but also high value indications.
Thomas: Such as advanced and metastatic advanced local in metastatic pancreatic cancer.
Thomas: Advanced recurrent ovarian cancer.
Thomas: Post COVID-19 conditions of chronic fatigue.
Thomas: In cognitive dysfunction. These are all important unmet medical needs that were challenging.
Thomas: On the corporate front.
Thomas: Our positive data in oncology was the catalyst for us to engage as a novo.
Thomas: Our specialized oncology business development firm and that is to drive our licensing discussion using skilled experts in the field.
Thomas: To engage.
The negotiation.
Of potentially valuable relationships with qualified partners.
We have a robust business development strategy for oncology.
Thomas: Involving our use of Avenova and that process is now underway.
Thomas: Yes.
Thomas: Importantly, my mandate and strategic imperative for the company early on was to broaden and.
Thomas: And take steps to secure our patent estate for ampligen, especially in oncology.
Thomas: As a priority we successfully continued to do just that.
Thomas: You'll note that we had the issuance of a key U S patent.
Thomas: And that's where we were protecting our use of ampligen in combination with <unk>.
Thomas: PDL, one checkpoint inhibitors, such as your value the Astrazeneca drug and.
Thomas: We've also made tremendous progress in the clinic with Ampligen combined with PD, one checkpoint inhibitors. So we're trying to establish in many tumors.
Thomas: Different tumor types and with different checkpoint inhibitors, and bluejeans ability to create synergy sometimes massive synergies.
Thomas: Now I believe that the clinical work that we do.
Thomas: It is very important not only for our business development strategy because for any potential future partner clinical progress de risks.
Thomas: Their investment.
Thomas: But also for our stockholders and investors to understand.
Thomas: Did all of this work also.
Thomas: Creates a foundation for long term value.
Thomas: Through 2023.
Thomas: This time last year.
So now we've had tremendous progress.
Thomas: This time last year, we hosted our inaugural earnings call.
Thomas: And quarterly thereafter, you know we are engaged in similar efforts.
Thomas: Updating and providing progress reports to our stockholders.
Thomas: In 2020, three we upgraded our website and we've been extremely.
Thomas: Effective and active on social media channels.
All of this demonstrates our commitment to good communication.
Thomas: Recently, we launched AMC E O corner to provide a portal on our website to further discuss important topics for the company and areas of interest to you.
If you have an interest in an area of interest you wanted suggest contact our IR portal and give them your ideas on what we should be talking about on CEO corner.
Thomas: We are all in this together.
Thomas: I'm a stockholder tune.
Thomas: And over the past several years I have personally invested what I believe is a substantial amount of money in it.
Thomas: I believe it is critical for management to stand shoulder to shoulder with our stockholders.
Thomas: And we will lock arms working together to move this company.
Thomas: Into its next phase of growth and what I believe.
Thomas: It's a phase it presents great opportunity.
None: It is now my pleasure to turn over this discussion to.
Speaker Change: Two our science officer, Dr. Chris Mac Alere he'll give you a detailed update on our progress in the various clinical trials and also I hope broaden your understanding of the mechanism of action of Ampligen, what it's doing in the immune system based upon recent data Chris.
Chris: Thank you Tom.
Speaker Change: Ampligen is a treatment for multiple indications from locally advanced and metastatic pancreas cancer, two advanced recurrent platinum sensitive ovarian cancer, it's a long COVID-19.
None: And I will take a few moments to briefly walk through some important aspects of our clinical portfolio.
Speaker Change: I will start with the study in advanced recurrent platinum sensitive ovarian cancer ongoing at the University of Pittsburgh.
Speaker Change: I have had an opportunity to review the preliminary data that will be included in the interim report and we will be releasing a statement in the very near future. Once the finalized report has been received.
Speaker Change: What I can say now is that based on the initial data. The safety profile is good. The objective response rate is better than the preliminary data that was reported in the April 2022 ACR abstract.
Speaker Change: And you remind all shareholders that the data presented at ACR indicated that ampligen and the ampligen Pembroke containing treatment had a four to five times greater objective response than that seen in the keynote 100 study.
Speaker Change: <unk> is not alone in recurrent ovarian cancer and the objective response rate being complete and partial tumor responses.
Speaker Change: The study has moved on to the second stage of the Simon two stage design. The data is very promising and recruitment rates have also accelerated post COVID-19. So all of those are positives.
Speaker Change: Detailed data from the planned interim report will be disseminated in the upcoming press release.
Speaker Change: We reported positive top line data for the $5 18 post Covid trial in February and I have also recently reviewed the preliminary copy of the complete study report.
We are currently working with <unk> to finalize that report at which time, we will begin deep analysis of the data and use that information to help inform the design of the next trial.
Speaker Change: The post Covid landscape is diverse and information is continually being generated that helps her find the scientific communities understanding of the disease and the trial was designed to collect preliminary data to appropriately power. The next trial as well as understand and refine inclusion criteria for the design of a successful phase II.
Speaker Change: The pivotal study.
Speaker Change: That analysis will likely take some time based on the over 32000 pages worth of data listing, but I am optimistic that based on the preliminary review of the data it is sufficient to design and power of the subsequent trial.
Speaker Change: Concerning our <unk> hundred 70 trial in locally advanced pancreatic cancer. We are currently preparing for a type b meeting with the FDA to discuss altering inclusion criteria for the IMD protocol.
Speaker Change: If we are successful it will expand the patient population that would be eligible for enrollment.
Speaker Change: I will speak further on this in the future after resolution of the type C meeting in the interim we are still recruiting and opening new sites and the current sites are still open for enrollment and are screening potential candidates.
Speaker Change: Hopefully upon successful consultation with the FDA the revised protocol will allow for faster recruitment of sites and patients in the U S.
Speaker Change: <unk> Medical center in the Netherlands should be open for recruitment any day now and we are engaged in conversations with other sites in the EU.
Speaker Change: That brings me to the door think study combining ampligen undervalue Mab therapy post full fair enough.
Speaker Change: The phase one portion of the trial is a three and three escalation design with fixed or value mab dosing with escalating ampligen dose. The first three patients of the three and three design have been enrolled already and two patients have completed their ampligen dosing and have received at least two devalue mad doses the last page.
Speaker Change: <unk> laughed ampligen doses in mid April and thus far there have been no reported adverse events.
Speaker Change: Once the patient completes the last ampligen dose and finishes the prescribed monitoring period, which should be around the end of April and assuming the safety profile is consistent as it has been thus far we can escalate to the next dose.
That trial, so far is going according to schedule and if that continues we expect the phase one portion to be completed in the summer of 2024.
Speaker Change: Lastly want to address the early access program in pancreas cancer.
Speaker Change: Enrollment in this program will halt as these patients should be enrolled in either door pang or amp $2 70.
Speaker Change: And from this program data was recently published in the Journal clinical cancer Research and these data highlight aspects of the mechanism by which ampligen exerts prolonged progression free and overall survival in pancreas cancer patients. These.
Speaker Change: These data were also part of the information used to design the door pain study and what gave further confidence that ampligen would work synergistically with the PDL, one checkpoint inhibitor devalue Matt.
Speaker Change: With that being said I'd like to take a second and look at ampligen effects in various different solid tumors.
Ampligen works by binding to toll like receptor three which are found on empathy ourselves and immune cells in the body.
Speaker Change: Solid tumors in different parts of the body are similar in that they formed from epithelioid tissue and therefore these tumors express toll like receptor three.
Speaker Change: Our hypothesis has been that ampligen will be an effective treatment in multiple solid tumor types.
Speaker Change: Because one it's binding to toll like receptor three found in the solid tumors, no matter, where that tumor might be in the body, whether it be pancreas, ovarian breast or otherwise and two the ampligen binding to the toll like receptor free three found on the surface of immune cells that are distributed throughout the body, including the tumor microenvironment.
Speaker Change: And this chart shows different immune Biomarkers and these are markers of immune cell chemotaxis, and dendritic cell or a T cell infiltration in the tumor microenvironment.
And this table might seem complicated so a more relatable analogy might be the ampligen forces the tumor to make it a 911 distress call to the immune system against its well shown here on the table by increases in <unk> 910, and CCL five and subsequently the immune system infiltrate the tumor and attacks it.
Speaker Change: Driven by Upregulation of Grand Zombie and CDA in this chart.
Speaker Change: And the table shows that the phenomenon happens in multiple different solid tumor types. We have investigated and therefore, we believe that ampligen has potential and not simply as a treatment for one specific form of cancer, but as a treatment for many types and.
Speaker Change: And importantly, I want to highlight that these immune modulating properties coupled with other biomarker data. We have suggests that ampligen would have considerable synergistic effects with immune checkpoint inhibitors.
Speaker Change: Our data in triple negative breast and ovarian cancer confirm that hypothesis and I believe this will be confirmed through the door think study for pancreatic cancer as well.
Speaker Change: And I'd now like to turn the presentation back over to Tom equals to discuss our key recent clinical and business milestones as well as what to expect in the coming months.
Tom: Thank you Chris.
Tom: I too am very excited about.
Tom: The opportunities that these clinical successes.
Tom: Provide.
Tom: This year we've hit.
Tom: Milestone after milestone.
Tom: In 2023, we've followed away going.
Going back over two years of positive data.
Tom: Data published in top journals and abstracts at major meetings.
Tom: Especially in oncology.
Tom: For Q2, we are planning for an action packed quarter.
Tom: Okay.
None: Now regarding our business development strategy.
None: As I mentioned, we hired as in Nova.
None: And now we believe is the time to redouble our efforts with their help.
None: The mandate browser, Nova is to drive our process.
None: For conversations with targeted potential.
None: Potential sponsors partners.
None: And create the value that comes in oncology from such deals.
None: If you look.
None: You'll see that the richest area of dealmaking.
None: For biotech.
None: As in oncology, that's where the most deals are that's where the most money is.
Business development takes time.
None: It begins with the creation of a sufficient database to support the discussion.
None: That's where we're at now.
From that point forward the cycle from introduction to a potential partner.
None: So the negotiation of a valuable transaction it doesn't just happen overnight.
Or with a few conversations.
None: Long term process.
None: Taking months, sometimes a year or more.
None: We do believe however that we have the right team and process in place to ensure we maximize the value of ampligen.
None: We also believe and this is why we're taking this step at this time is that these decisions by the bigger pharma companies to acquire rights into drugs and oncology drugs are data driven decisions and we are now sitting on data.
None: Allows us to have that discussion and we have additional data coming in we think will amplify.
None: At this point.
Now what are we trying to do there are a number of different things that are possible. If we have an interested a business partner.
Partnering traditional partnering co development licensing deals, even M&A opportunities might be up here we.
None: We believe 2024 is an integral year for this process. We have the data we have the team and we intend to make important strides with our discussions with these potential partners over the course of this year.
None: Now, let's take a look at our financial snapshot.
None: The numbers are there the details are in the 10-K that we just filed.
None: The important thing to take from this is we have the wherewithal.
To go forward with our programs.
For the next.
None: Year and.
None: And a half or so.
None: This is this is the the answer you know when you look at what you're seeing here is we have the ability to continue our programs into the future and we have important programs that are underway.
None: Christian I believe the future is bright.
None: For both aim and ampligen.
None: The entire aimed team.
None: It's behind Us driving this strategy forward.
None: Our programs.
None: Our operational activities and our clinical execution has been superb.
None: We believe we will continue to deliver promising data across several important indications all of which have the potential to create huge market opportunities.
None: Now all of this is done to drive forward.
None: Aim in ampligen.
And unlock ampligen op opportunity to provide therapeutic value.
None: Our medical and scientific success success, though is not just.
None: Good medicine.
None: I firmly believe the good medicine.
None: <unk>, good business and our strong clinical showings that we've posted over the past two years as well as what we expect in the future is a basis for driving stockholder value.
None: At this time I'd like to open the floor for questions.
None: Thank you will now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment.
None: Necessary to pick up your handset before pressing star one one moment please poll for questions.
Jason Mccarthy: Our first question today is coming from Jason Mccarthy from Maxim Group. Your line is now live.
Jason Mccarthy: Hi, guys. Thanks, taking the questions. This is Chad on for Jason So for Amp to 70 I was just wondering if you could give a bit more clarity on timing for first patient dosed as that.
Jason Mccarthy: Just think of that as you know <unk> four choke on anything there.
Jason Mccarthy: Okay.
Jason Mccarthy: Well, we certainly have every expectation that in Europe, we will certainly by the end of the year have people not only enrolled but in treatment.
Jason Mccarthy: That's a not something we can say in the U S. Because there's a difference in the standard of care between Europe, and the U S. It seems to be affecting the ability to get full enrollment in the U S, which is why we're having the meeting with the FDA I can't go into the details of that ahead of time, but.
Jason Mccarthy: But we hope with some amendments to.
Jason Mccarthy: To the protocol to broaden the inclusion criteria will also start to get the kind of U S. A.
Jason Mccarthy: Candidates and subjects are recruited.
Jason Mccarthy: And in treatment as well.
Jason Mccarthy: Chris would you like to talk to that a little bit.
Chris: Indeed I.
Chris: The type B meeting should be scheduled here shortly and when we have that conversation with the FDA, it's about altering your inclusion criteria.
Chris: The U S does things a little bit differently than Europe does in terms of.
Chris: How they treat.
Chris: Patients with locally advanced pancreatic cancer.
Chris: And you know we need to take that further into account and we understood that when the trial was designed but.
Chris: Perhaps to the extent that they want to include radiotherapy is it was a little more than expected.
Chris: And so you know the I assume that after the type C meeting is over I hope that the FDA will agree to the changes that we are to be made and I think that will.
Chris: Catapult enrollment in the U S. So I expect.
Chris: Enrollment in the EU to happen in Q3, Q4 ish by the end of the year for sure and in the U S as well.
None: Okay, great. Thanks for taking the questions guys and congrats again on the quarter.
None: Thank you.
None: Thank you as a reminder, that star one to be placed into the question queue. Our next question is coming from James Molloy from Alliance Global Partners. Your line is now live.
Hey, guys. Good morning, Thank you very much for taking the questions.
James Francis Molloy: I had a question sort of on the.
James Francis Molloy: The investigator sponsored trials, they've got a variety of metastatic prostate triple negative.
James Francis Molloy: Ovarian cancer, a variety of of Isps ongoing I know there outside of your control but.
James Francis Molloy: With any any insight you could give us like where do you think we might be seeing some potential data in and out of any of those Isps.
James Francis Molloy: Well, we have every expectation of getting the formal interim report on the advanced recurrent ovarian cancer phase two that's the program that was started in Pittsburgh with Merck Grant and Combi.
Mining ampligen with Penn Burleson, ma'am to see if we can improve the.
James Francis Molloy: Therapeutic efficacy over and above what remember Elysium Mab alone was able to do.
James Francis Molloy: That should be extremely positive data because we've seen preliminary data come in consistently positive.
James Francis Molloy: Positive and showing them a massive increase in a therapeutic.
James Francis Molloy: Impact, especially with regard to R. R.
James Francis Molloy: So I think that's going to be very powerful. These investigator sponsored trials are extremely important.
James Francis Molloy: Because while we're supplying the ampligen and everything it and for the most part are the big part of it will be expenses in those trials is covered by various grants either industry grants.
James Francis Molloy: Or governmental grants typically.
Does that answer the question.
None: Yeah. It does thank you very much.
Then on the 518 I know the final datasets can be coming out here in second quarter what are.
None: What does it what does it alerting you to just be getting now that with the unfortunate data back in February of what additional data, you're hoping to sort of parse out of the final dataset essentially going forward does it go for the 4518.
Well the data we received in February had a lot of very positive point.
None: And that top line reporting and the complete dataset.
None: It has come in but I think it's you know tens of thousands of pages. So are our ability to.
None: Do that analysis will take some time, but it's underway.
Unknown Executive: I'll turn this over to Dr. Michael <unk> for any detailed comments Chris.
Unknown Executive: And so the complete study report will have breakdown of all of the secondary endpoints that werent part of the topline data we've seen knows and there are positive.
Unknown Executive: <unk> and quite a few of those.
Unknown Executive: The it also give us the individual data points for a statistical analysis empower analysis to be done.
Unknown Executive: Im also hoping that the you have to wait for the biomarker analysis to come in but it's clear from the initial review of the data that there are responders and non responders is as we would expect and the understanding of the inclusion criteria and the initial baseline data in those individual patients who responded versus or not.
Unknown Executive: <unk>.
Unknown Executive: Give us an indication of how we want to design the study in the future secondary to that.
Unknown Executive: Mind, everyone that you the.
Landscape of post Covid, and how you use statistical analysis and standard deviation to power. The study didn't necessarily exist for us. So we chose 80 patients as a.
Unknown Executive: Clinical judgment right and that data is used now to power. This study appropriately.
Unknown Executive: If.
Unknown Executive: Even the data that currently exists I believe powered properly would've given us statistical significance over the course of the study as the data would suggest there are improvements in both cognitive function fatigue six minute walk test.
Unknown Executive: And sleep as well in these patients and so I believe the data will give us enough information for us to design the trial to be successful with high level of power for the next trial.
None: I might just add.
None: The point of this was a what's called a proof of concept because of the small number of subjects 80 80 subjects is it's a very small phase two and it's usually design for exactly the purpose that we've just articulated but but what we are in.
None: Tend to do is take that data and refine our inclusion criteria. So.
None: We're focused on bringing subjects into this trial. The this follow up trial.
None: Uh huh.
None: Have a high confidence that we've targeted.
None: The zone of Ampligen responders and much of that is going to be based upon the onset of disease and we believe that.
None: The longer they've had post COVID-19 chronic fatigue like symptoms are the more likely we will see statistically significant responses, especially with severe disease, which is much easier.
None: Easier to measure than people with mild or moderate disease. So so Chris anything you want to add to that and we'll just see if Mr. Malloy is no.
None: That sums it up.
None: Does that answer your question Jim.
None: It does indeed had no call me Mr. Miller.
None: I appreciate it and then I guess the last question housekeeping.
None: G&A are pretty high in the K you guys talk about the $6 5 million in legal expenses you had to spend.
None: In the year, presumably you don't anticipate hopefully that that same level.
None: G&A with the.
None: With legal expenses going forward in 2024.
None: Well, we hope that we don't have those expenses are again for 2020 for we've are in the in the Chancery Court.
None: This group on.
None: The related group.
None: From on three separate occasions, it's up in the Delaware Supreme Court right now after our last trial.
None: We we are we have to take a stand though if it's this particular group because as the Chancery court and one of its orders related to the the second attack with Georgia.
None: That.
None: This whole thing was orchestrated by Securities Law, Pelon, and and then the payment.
None: Funding of it was managed.
None: Managed by another financial fraudster convicted felon, so you can't allow.
None: That to go forward with.
None: Addressing those issues.
None: Thank you for taking questions.
Thank you next question is coming from Ed Woo from <unk> capital markets. Your line is now live.
Edward Moon Woo: Yeah. Congratulations on all the progress that you're doing my question is the Covid landscape has changed significantly obviously as we move further and further away from the initial startup. The pandemic can you talk about the market opportunity for long Covid today.
Edward Moon Woo: Certainly Mr where we've got.
Edward Moon Woo: Situation in the United States.
Edward Moon Woo: That is ever increasing in terms of its social impact.
Edward Moon Woo: Looking at millions of Americans are they're expected to have a serious.
Edward Moon Woo: Post COVID-19 chronic fatigue like conditions, which is posted.
Edward Moon Woo: Posted exertional malaise debilitating fatigue cognitive dysfunction sleep.
Edward Moon Woo: Leap interruption in severe joint pain. So so that that's a disabling disease that is ever growing.
Edward Moon Woo: And it's.
Edward Moon Woo: I believe right now estimated at about a 4 million potential.
Edward Moon Woo: Persons.
Edward Moon Woo: It will suffer from this going forward in the United States alone that numbers.
Naturally higher worldwide of course.
None: Great well, thanks for answering my questions and I wish you good luck.
None: Well, thank you very much.
None: We really appreciate your interest.
None: We reached end of our question and answer session and ladies and gentlemen that does conclude today's teleconference and webcast. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.
None: Yeah.
None: Yeah.