Q3 2024 AIM ImmunoTech Inc Earnings Call
Hello, and welcome to the aim of immuno Tech third quarter 2024 update conference call and webcast.
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As a team our chief Executive Officer, Thomas equals and scientific officer, Dr. Christopher macro layer.
Thomas Equals: I would now like to turn the call over to Mr. Equals. Please proceed.
Thomas Equals: Thank you very much operator, and I'd like to thank everyone for joining us this morning.
Thomas Equals: Throughout the third quarter, we have made solid progress with the advancement of our lead product.
Thomas Equals: Ampligen.
Thomas Equals: By this I mean, our team continued to execute on our clinical and regulatory strategies with their ampligen development programs across several indications and I want to remind you that these are areas with critical unmet needs, especially in the high value pancreatic cancer space.
Thomas Equals: Importantly, we continue to deliver positive clinical trial data across our pipeline and we believe this progress is driving significant momentum.
Thomas Equals: I'll briefly highlight our progress and then turn the discussion over to our Science officer, Dr. Mcaleer to dive deeper into our programs and our progress.
We recently announced positive preliminary data from the phase one B two study, which we called <unk> evaluating the combination of ampligen.
Thomas Equals: Also known as rent it told them on and Astrazeneca is anti PD, one immune checkpoint inhibitor and busy also known as Joe value man in the treatment of late stage metastatic pancreatic cancer.
Thomas Equals: During the third quarter, we also announced the great news.
Thomas Equals: The complete clinical patient data from our <unk> clinical trial supports our belief in the ampligen as a potential therapeutic for a subset of people with moderate to severe post COVID-19 conditions of fatigue.
Thomas Equals: These data for that group are statistically significant and allow us to target the subject population for Ames planned follow up clinical trial.
Thomas Equals: We are amassing a growing body of data and continue to report as well as publish our data at scientific congresses in prestigious journals and publications supporting Ampligen as both both a monotherapy and combination therapy with other approved drugs.
Thomas Equals: During the quarter, we announced official print publication of the data analysis from Erasmus from a long term early access program studying ampligen for the treatment of advanced pancreatic ductal adenocarcinoma.
Thomas Equals: No carcinoma also known as P. D a C.
Thomas Equals: The manuscript appeared in the journal clinical cancer Research, which is one of oncology as most prestigious journals. These.
These data continue to provide us with further insights into ampligen ability to improved progression free survival and overall survival and enable us to identify cancer patients who might benefit more from ampligen treatment than they would from other known cancer treatments.
Thomas Equals: Building, our IP portfolio for Ampligen also remains an important priority for the company and we continue to identify ways to expand our patent estate, we recently announced that the United States patent and trademark office granted to me and our medical officer, Dr. David Strayer, our composition of matter and methods of treating.
Thomas Equals: <unk> pattern.
Thomas Equals: Rich, we have assigned Duane comprising ampligen in the treatment of endometriosis.
Thomas Equals: As you May know endometriosis is a painful chronic condition that affects nearly 10% of women of reproductive age or approximately $6 5 million women in the United States.
With the global endometriosis market already and an estimated $2 $4 billion in 2023. It is expected to reach $3 7 billion by 2032.
Speaker Change: We believe this addition to Ames Ampligen patent portfolio makes the company and even more attractive partnership whereby out target.
Speaker Change: As to our finances, we are currently disputing in negotiating $4 9 million in accounts payable.
Speaker Change: We hope for a positive resolution.
Speaker Change: Further and a related issue one of the main DNO insurance companies has so far failed to pay a $2.5 million secondary layer of coverage.
Speaker Change: We are working to obtain prompt payment.
Speaker Change: These are major factors regarding the going concern and stockholder equity issues, which we're working hard to resolve in a positive fashion.
Speaker Change: I am very pleased with our continued progress and believe we are driving significant momentum with.
Speaker Change: With our positive clinical trial data and this is fundamental to our overarching strategy of driving ampligen towards approval and underscoring potential big pharma collaboration and commercialization opportunities.
Speaker Change: With that I'd like to turn it over to our Science officer, Dr. Christopher Mcaleer to discuss it in more detail our progress and plans for ampligen across our pipeline Chris.
Thank you Tom.
Speaker Change: We have a bit to cover today and I will start with our programs in pancreatic cancer.
Speaker Change: <unk> is a phase one two trial to determine the safety and efficacy of combining ampligen with astrazeneca as their value add in the treatment of metastatic pancreas cancer.
Speaker Change: We recently announced that the 200 milligram dose was deemed safe and we were able to proceed to 400 milligram dosing of ampligen.
Speaker Change: The study encountered some last minute screen failures, and there will need to be at least one additional patient enrolled to gather the necessary dose limiting toxicity data to complete the phase one b.
Speaker Change: The study is on track for the final patient to be enrolled by the end of the calendar year.
Speaker Change: Thus far there have been no serious adverse events at either the 200 or 400 milligram doses and we expect a smooth transition to phase two.
Speaker Change: As we reported earlier two of the three patients in the low dose cohort had stable disease at the six month time point and higher dose cohorts have yet to reach the six month assessment.
Speaker Change: However of this six evaluable patients that have reached the three month evaluation time point and this does include both 204 hundred milligram dosing five of the six patients that's 83% had stable disease at the three month time point.
Speaker Change: Erasmus has a large cohort of historical data and comparably only 20% of historical patients has stable disease at that time point.
Speaker Change: The first patients in the 400 milligram cohort are approaching the six month assessment over the next few weeks and two of the three patients still have stable disease.
Speaker Change: When evaluating progression free survival from the startup for fear of not utilizing the standard Kaplan Meier time to that analysis and I caveat. This by saying these data are preliminary and only from these few door paying patients. The door panel combination has a current progression free survival of 15 months compare.
Speaker Change: 12 months of Ampligen alone, which is data from our EAP and compare that to eight months with historical controls. These.
Speaker Change: These are improvements in progression free survival of four months with ampligen alone and seven months with the combination of Ampligen and Astrazeneca is there value map.
Speaker Change: To put that into context, when full fear Nox replace Gemcitabine paclitaxel as the standard of care in metastatic pancreas cancer the improvement in progression free survival was approximately three months.
Speaker Change: We are encouraged by these data and we anxiously await the last patient enrollment in the dose limiting toxicity evaluation for the formal launch of the phase two which we anticipate occurring in Q1 2025.
Speaker Change: Concerning the Amp to 70 trial involving ampligen as a maintenance therapy for locally advanced pancreatic cancer. We have edited the protocol. According to our discussion with the FDA and we submitted the protocol to the FDA for comments in October.
Speaker Change: While not mandatory we were awaiting the customary 30 days to allow for FDA comments at this time clinical trials Dot Gov has been updated the protocol has received IRB approval and we are disseminating the new protocol to sites to begin the enrollment process.
Speaker Change: As I stated before this protocol expands the inclusion criteria and treatment arms to allow for those patients receiving chemo radiotherapy and we believe the addition of these treatment arms will accelerate patient and site recruitment.
Speaker Change: I'm hesitant to forecast a first patient enrollment under this new protocol as I anticipate that there will be further negotiations with current sites concerning budgets related to the new protocol design.
Speaker Change: In addition, we have compiled a targeted list of institutions to Reengage with for site recruitment and we expect all of this to be in full motion within the next few weeks.
Speaker Change: Regarding ampligen for the treatment of ovarian cancer.
Speaker Change: As we discussed in our last earnings call the trial, combining ampligen cisplatin and Pembroke lives in that for the treatment of advanced recurrent ovarian cancer is being wrapped up early Dr.
Speaker Change: Doctor Edwards was so impressed with the response rate and the level of tumor infiltrating lymphocytes that he has convinced burke to allow the trial to be downsides from 45 patients to 30 they.
Speaker Change: They are wrapping up enrollment and hope to submit a manuscript highlighting the data collected thus far for peer review by the end of the calendar year.
Speaker Change: In the phase II study in advanced recurrent ovarian cancer, combining the ampligen containing CK M with cisplatin and a dendritic cell vaccine is open for recruitment and awaiting first patient enrollment.
Speaker Change: Concerning our phase two trial for the post COVID-19 condition of fatigue. The final complete study report has been approved and the data for this trial will be posted to clinical trials Gov by the end of November the.
The exploratory biomarker data has been received and there are very interesting findings between healthy and disease patients and we are engaged in conversation with other scientists and advocacy groups determine how these data fit into the greater understanding of the disease and how best to utilize the information.
Speaker Change: In addition, it is clear that ampligen modulate certain biomarkers.
Pertaining to complement mediated pathways and immune cell maturation among others.
And we are still working through the predictive nature of the biomarkers to identify responders.
Speaker Change: This is a time consuming process as we investigated over 2000 different proteins. We've utilized machine learning algorithms like principal component analysis with least squares differentials to parse the data. It is clear that there are distinct populations of patients and we're still determining how best to use these data to target the optimal population.
Speaker Change: Patients for enrollment.
Speaker Change: In addition, I was invited to attend to recover TLC, that's treating along Covid kickoff meeting at the NIH campus in Bethesda. It was a wonderful opportunity to discuss the successes and failures of the original recover program and to lay groundwork for the design of the next treatment strategies as well as a wonderful opportunity to network with public and private.
Speaker Change: Partners that are interested in funding and treatments for long COVID-19.
Speaker Change: As many may be aware the recover TLC program has launched a portal for submission of potential therapeutics to be tested as part of this initiative.
Speaker Change: We have submitted ampligen as a candidate to be included in their clinical trials and if chosen the NIH would assume the costs and wood with consultation with AME and other partners drive the clinical and regulatory pathway of ampligen for the treatment of long Covid.
Speaker Change: We are hopeful that ampligen will ultimately be chosen to be included in this program.
Speaker Change: Now I'd like to switch focus for a minute while these calls and presentations tend to focus on the clinical trials, where in aim is testing ampligen and treatment of diseases and disorders. We are also always working behind the scenes to identify and exploit any inefficiencies possible to make ampligen a better more desirable.
Speaker Change: Product for potential partnerships and buyouts.
Speaker Change: I felt since I joined aimed at the polymer manufacturing process could be improved and potentially shortened which would ultimately save money.
Speaker Change: To that end, we have spent the past year working with Sterling pharma solutions, which is our manufacturing partner in the United Kingdom to optimize and streamline the production of the individual poly I and policy 12, you polymers that are the building blocks of ampligen.
Speaker Change: Through an upfront investment of a little over $200000 in R&D experiments and the combined creativity of the aim in Sterling science teams, we have been able to remove certain processing steps that utilize hazardous chemicals, while also shortening the polymer production time by approximately 40% and all of this is with a minor loss of yield.
Speaker Change: But importantly, still meet any established releasing quality specifications. This optimization should save aim an estimated $2 million total and the ongoing method transfer and validation process with Sterling, while also reducing future costs by about 200000.
Speaker Change: For each batch of ampligen.
Thomas Equals: And now I'll hand, it back to Tom to discuss the company financials. Thank you very much Chris I'd like to direct everybody to slide number nine excuse me slide number eight which addresses our audited financials.
And the state that are we've covered a lot of our fundamental progress today.
Our priorities are focus our enthusiasm our vision and our mission has never been clear.
Thomas Equals: The strength of our growing body of data across multiple indications is both robust and highly encouraging.
Thomas Equals: We are driving significant momentum across multiple clinical programs and studies that are demonstrating ampligen significant potential to address high value and high need indications, especially in the pancreatic cancer space.
Thomas Equals: Over the course of 2024, our team has made important progress in executing our clinical strategy facilitating potential partnerships, including with big pharma and leveraging commercialization opportunities to create value. The entire aim team is dedicated to <unk>.
Thomas Equals: <unk> patients in need and delivering enhanced value for our shareholders.
Thomas Equals: I would like to inform you that aim immune attack has found a definitive proxy statement.
Thomas Equals: And related proxy materials with the SEC in connection with the 2024 annual meeting of shareholders.
Thomas Equals: And then connection there with its directors.
Thomas Equals: And executive officers Peter W. Ridener third and Robert Dickey reports are participants in the solicitation of proxies from our shareholders in connection with such annual meeting.
Thomas Equals: Aim shareholders are strongly encouraged to read such proxy statement and all other related materials filed with the SEC carefully and in their entirety as they contain important information about the 'twenty 'twenty four annual meeting.
Thomas Equals: As you May know a.
Thomas Equals: A group of activist investors has nominated for individuals to replace our entire board.
Thomas Equals: We have issued a detailed public letter on this but I want to make a few points on this call.
For the third year in a row several individuals in this group are trying to take control of our board.
Thomas Equals: We have serious reservations about this group's members which include individuals with checkered past and close ties to security law felons.
This in our view indicates they would not be good stewards of stockholder resources.
Thomas Equals: The group has also made clear in their proxy materials that they personally will seek substantial monetary reimbursement for over $5 million for their 2023 failed attempt to take over the board. In addition to whatever expenses. They may incur in connection with this year's annual meeting.
Thomas Equals: Each without giving shareholders a direct sale.
Speaker Change: Needless to say aims cash is essential to funding our runway for ongoing research and clinical trials Keith.
Keith: Keeping up the positive momentum we've seen across high value indications.
Speaker Change: Which Chris and I have discussed earlier in this call is what will allow us to unlock long term value for all shareholders.
Each of our incumbent directors strongly believes that if the Actavis group gained control of the board our progress and momentum would be put in jeopardy, and the company's cash position could be severely depleted if and when they reimbursed themselves.
Speaker Change: The bottom line in our view the activist group is looking out for itself not for all shareholders and the election of their nominees who have not even put forth any serious plans for the future of the company would be detrimental to all stakeholders.
Speaker Change: That is all I'm going to say on this subject on the call.
Speaker Change: So I ask that your questions be limited to our business and financial results from the quarter.
Speaker Change: So with that I'd like to turn now to questions and answers operator.
Speaker Change: Thank you at this time, we'll be conducting a question and answer session if you'd like to ask a question.
Speaker Change: Please press star one on your telephone keypad.
Speaker Change: Confirmation tone will indicate your line is in the question Kim.
Speaker Change: 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 up your handset before pressing the star keys, one moment, please while we poll for questions.
Speaker Change: Thank you. Our first question comes from the line of Chad yet with Maxim Group. Please proceed with your question.
Speaker Change: Hi, guys. Thanks for taking my question and congrats on the progress.
Was wondering if you could provide some additional color on the next steps for the long Covid program and what the potential next studies done there could look like.
Well, thank you very much for the question and.
We're utilizing the data that the analysis has just been completed to formulate a a profile for inclusion in that our next trial.
Speaker Change: The the the group that's been identified as having a significant response with statistical significance as a in the moderate to severe category of the disease.
Speaker Change: And I like to allow Dr. <unk> to address a few points related to the specifics of the data and also maybe the input that we see generally from the Biomarkers.
Speaker Change: Thank you for the question.
Speaker Change: The the path forward will partially depend on whether Apple has chosen didn't recover TLC program.
Speaker Change: It's recovering for the TLC program most of that Ah clinical design will be part of their platform study and the readouts and such will be driven in combination with our input by the NIH.
Speaker Change: Author funded by the NIH.
Speaker Change: If it's not chosen we have.
Speaker Change: We have.
Speaker Change: Look through the data and we found that those who are our most severe the home ambulatory patients respond best to Ampligen. We've also found blood biomarkers that show those that have markers of of anemic events and or immune cell deprivation.
Speaker Change: To respond better to ampligen as well.
Speaker Change: And so the design of the trial you will incorporate those elements right. So we're looking at the most severe moderate to severe patients that had particular biomarkers that we're looking at that.
Likely the outputs will be something related to 50 or post exertion of malaise.
Speaker Change: And.
Speaker Change: The design will likely be some sort of phase two three trial.
Speaker Change: And if I might add that the and five to 18.
Speaker Change: As a part of our concept was to have a relatively broad net for inclusion.
Speaker Change: So we could identify not just who responded well to ampligen, but where we did not get a significant response in the patient population. So so it did its job.
We do see a segment of that population, which Chris just described are.
Speaker Change: Where there's a data that establishes an opportunity to help people move from home ambulatory to community ambulatory, which is a big step in terms of therapeutic improvement and that data was statistically significant.
Speaker Change: That was very helpful. Thanks, gentlemen.
Speaker Change: Youre welcome.
Speaker Change: Thank you. Our next question comes from the line of Ed Woo with <unk> capital markets. Please proceed with your question.
Speaker Change: Yeah, congratulations on all the progress.
Speaker Change: I was curious about you mentioned that you were able to reduce the cost and time to produce a batch of ampligen, how much does it cost and how much time does it take to produce a batch and also is there any opportunities to improve that going forward even further.
Speaker Change: And we do have plans to continue to work on developing efficiencies in the manufacturing process and in in a bigger picture if.
Speaker Change: If we are able to reach an.
Speaker Change: An arrangement with a larger pharma company for development and and actual.
Speaker Change: Commercial distribution of the drug that will allow for mass production of ampligen, rather than production of small lots, which which mass production.
Speaker Change: Niques will create tremendous savings on a per barrel basis.
Speaker Change: Chris do you want to go into some of the things that we're working on right now.
Speaker Change: Yes.
Speaker Change: Necessarily want to go into the details of it but we're looking at the patent ability of the process that we have ongoing right now the polymer production process is about 400000 per.
Speaker Change: Bachelor Polyamide policy 12, U we have reduced that down to approximately 200000 with this production. It is still a batch production process I do believe that we can turn that into a continuous flow process, but we're doing this iteratively I think when we get that to a continuous flow process, we can probably.
Speaker Change: Increased production by three or four fold for the same production cost.
Speaker Change: That.
Speaker Change: These changes that we've made to the polymer production don't necessarily affect the fill and finish process of taking that API into ampligen, which currently is in a batch production. However that batch production of Ampligen is currently limited by the quantity of polymer that we can make at any one time when.
Speaker Change: When we go to a continuous flow process of the polymer production and create that into larger quantities. We can increase the batch size production of ampligen from approximately 9500 vials to I believe somewhere around 30 to 35000 in production and in doing so we can locally projected reduction in costs by about 60.
Speaker Change: Or 70%.
Which would take us somewhere from the 600000 down to three 250000.
Speaker Change: Dr. <unk> does that answer your question.
Speaker Change: Yes. It does thank you very much and I wish you guys. Good luck. Thank you.
Speaker Change: Thank you. Thank you for your interest.
Speaker Change: Thank you ladies and gentlemen, this concludes our question and answer session and thus concludes our call today. We thank you for your interest and participation you may now disconnect your lines.