Q1 2024 AIM ImmunoTech Inc Earnings Call
Operator: Hello and welcome to the AIM ImmunoTech First Quarter 2024 Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during this event, please press star zero on your telephone keypad.
Hello, and welcome to the aim of immune attack first quarter 2024 update conference call and webcast. As a brief reminder, all participants are currently in a listen only mode. If anyone requires operator assistance. During this event. Please press star zero on your telephone keypad.
Operator: Following the presentation, there will be a question and answer session. Please note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainty. Forward-looking statements in this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on AIM ImmunoTech's current expectations, and actual results could differ materially.
Following the presentation, there will be a question and answer session.
Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website. Following the end of the event.
Operator: As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports AIM ImmunoTech files with the Securities and Exchange Commission. These documents are available in the Investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research.
Speaker Change: At this time I'd like to remind our listeners that remarks made during this webcast may state managements intentions beliefs expectations or future projections.
Speaker Change: These are forward looking statements and involve risks and uncertainties.
Speaker Change: We're looking statements on this call are made pursuant to the safe Harbor provisions of the federal Securities laws and are based on aim immuno teck's current expectations and actual results could differ materially.
Speaker Change: Okay.
Speaker Change: As a result, you should not place undue reliance on any forward looking statements.
Speaker Change: Some of the factors that could cause actual results to differ materially from those contemplated by such forward looking statements are discussed in the periodic reports aim immuno tech files with the Securities and Exchange Commission.
Speaker Change: These documents are available in the investors section of the company's website and on the Securities and exchange Commission's website.
Speaker Change: We encourage you to review these documents carefully.
Speaker Change: Additionally, certain information contained in this web cast relates to or is based on studies publications surveys and other data obtained from third party sources and the company's own estimates and research.
Operator: While the company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or that any independent source has verified, any information obtained from third-party sources.
Speaker Change: While the company believes these third party sources to be reliable as of the date of this presentation. It has not independently verified it makes no representation as to the adequacy fairness accuracy or completeness of Where's that any independent source has verified any information obtained from third party sources.
Operator: Joining us on today's call from the AIM ImmunoTech leadership team are Thomas Equels, Chief Executive Officer, and Dr. Christopher McAleer, Scientific Officer. I will now turn the call over to Mr. Equels. Please proceed.
Speaker Change: Joining us on today's call from the immune attack leadership team are Thomas equals Chief Executive Officer, and Dr. Christopher Abacavir Scientific Officer I.
Speaker Change: I will now turn the call over to Mr. Equals. Please proceed.
Thomas K. Equels: Thank you, Operator. Welcome, everyone, and thank you very much for your interest in AIM ImmunoTech. I'm very pleased with our progress over the past several months. To summarize, on the clinical front, with our DuraPanc study, we took an important step forward in the testing of the combination of Ampligen with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor MFIZI, also known as Dervalu, for the treatment of late-stage metastatic pancreatic cancer. This is pursuant to a collaboration agreement that we have with AstraZeneca and Erasmus Medical Center, and it is moving at full speed ahead.
Thomas K. Equels: Thank you operator, welcome everyone and thank you very much for your interest in immuno tech.
Thomas K. Equels: I'm very pleased with our progress over the past several months to.
Speaker Change: To summarize on the <unk>.
Speaker Change: <unk> with our <unk> study, we took an important step forward in the testing of the combination of ampligen with Astrazeneca is anti PD, one immune checkpoint inhibitor <unk> also known as <unk> for.
Speaker Change: For the treatment of late stage metastatic pancreatic cancer.
Speaker Change: This is pursuant to our collaboration agreement that we have with Astrazeneca and Erasmus Medical Center and it is moving at full speed ahead.
Thomas K. Equels: As we reported, the investigator at Erasmus Medical Center in the Netherlands completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the Phase 1b-2 study. The combination of Ampligen and Imfizy was found to be generally well tolerated with no severe adverse events or dose-limiting toxicity. We are very encouraged as we continue to see a consistent safety profile across our oncology pipeline in multiple indications.
Speaker Change: As we reported the investigator at Erasmus Medical Center in the Netherlands completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the phase one b slash two study.
Speaker Change: The combination of Ampligen and does he was found to be generally well tolerated with no severe adverse events or dose limiting toxicity.
Speaker Change: We are very encouraged as we continue to see a consistent safety profile across our oncology pipeline in multiple indications.
Thomas K. Equels: Based on these positive results, escalation to the next dose level of DuraPanc will occur according to the protocol design, and we expect the next cohort of patients to begin dosing very soon. We also announced top-line interim data indicating that the combination of Ampligen with Keytruda, also known as Pembrolizumab, in the treatment of recurrent ovarian cancer may have a very powerful synergistic effect The investigator concluded that combination therapy could be far more effective than pembrolizumab alone as a therapy for this dreadful disease.
Speaker Change: Based on these positive results escalation to the next dose level endure panic will occur. According to the protocol design and we expect the next cohort of patients to begin dosing very soon.
Speaker Change: We also announced the topline interim data, indicating that the culmination of ampligen with Keytruda also known as Pam realism in the treatment of recurrent ovarian cancer may have a very powerful synergistic effect.
Speaker Change: The investigator concluded the combination therapy, it could be far more effective than <unk> alone as a therapy for this disease.
Thomas K. Equels: These interim data clearly suggest that there may be a massive positive impact on efficacy when Ampligen is combined with Pembrolizumab for the treatment of recurrent ovarian cancer. Other research suggests a similar effect on other solid tumor types.
Speaker Change: These interim data clearly suggests that there may be a massive positive impact on efficacy. When ampligen is combined with ambarella is a minimum for the treatment of recurrent ovarian cancer.
Other research suggests a similar effect on other solid tumor types.
Thomas K. Equels: This means we can see ampligen as a potential combination therapy, having therapeutic potential across multiple types of solid tumors and possibly even with different checkpoint inhibitors. Now, Dr. Chris McAleer, our science officer, will be talking in more depth about our lead clinical programs in just a few minutes. On the operational front, we have successfully completed the CGMP manufacturing of 9,042 clinical vials of AmpliChem. This repeatable manufacturing expertise represents a critical component of our overall commercial and business development strategy.
Speaker Change: This means we can see in ampligen.
Speaker Change: Potential combination therapy, having therapeutic potential across multiple types of solid tumors, and possibly even with different checkpoint inhibitors.
Speaker Change: Now Dr. Chris macro layer, our science officer, we'll be talking in more depth about our lead clinical programs in just a few minutes.
Speaker Change: On the operational front, we have successfully completed.
Speaker Change: Cgmp manufacturing of 9042 clinical barrels of ampligen.
Speaker Change: This repeatable manufacturing expertise represents a critical component of our overall commercial and business development strategies.
Thomas K. Equels: Our record of successful manufacturing is important as we seek commercial partners as well as for establishing ampligen reserves for ongoing and upcoming clinical trials. And finally, on the corporate front, Dr. Charles Lapp recently joined the company's medical and scientific team. Dr. Lamp is a very well-respected and well-known, world-class player in the disease of ME-CFS, and he played a key role in our long-standing AMP 511 expanded access program for the treatment of ME-CFS and long COVID.
Speaker Change: Our record of successful manufacturing is important as we seek commercial partners as well as for establishing ampligen reserves for ongoing and upcoming clinical trials.
Speaker Change: And finally on the corporate front, Dr. Charles Lapp.
Speaker Change: Recently joined the company's medical and scientific team.
Speaker Change: Doctor lamp is a very well respected and.
Speaker Change: Well known World class play.
Speaker Change: Player in the disease of Emmy CFS. He played a key role in our long standing and 511 expanded access program for the treatment of M Etfs and long Covid.
Thomas K. Equels: Of note, he founded and led one of the clinical trials key sites, the Hunter Hopkins Center in Charlotte, North Carolina, from which he recently retired. As a consulting medical officer and an independent contractor, he will help manage the company's research programs related to MECFS and Long COVID, including the development of protocols and new clinical trials. All of this progress, in just a few short months, continues to demonstrate our commitment to advancing our pipeline and operational execution. And I'll turn over the call to Dr. McAleer, our science officer, to discuss our priority pipeline programs. Chris, please. Thank you, Tom.
Doctor lamp: He founded and led one of the clinical trials key sites. The Hunter Hopkins Center in Charlotte, North Carolina from which he recently retired as a consulting medical officer and an independent contractor. He will help manage the company's research programs related M. Etfs in long COVID-19, including the development of protocols and new clinical.
Speaker Change: Trials.
Speaker Change: All of this progress in just a few short months continues to demonstrate our commitment to advancing our pipeline and operational execution.
Speaker Change: And now I'll turn it over the call to Dr. Mcaleer of Science officer to discuss our priority pipeline programs Chris Please thank.
Christopher McAleer: Thank you, Tom. I'd like to give a brief status update on our LEAD program. The FDA has granted our Type D meeting request regarding the AMP270 study in locally advanced pancreas cancer, and according to their proposed timeline, we should have preliminary answers in late June. Assuming that AIM and the FDA are in agreement, we will then be able to move forward with expanding the patient population that would be eligible for enrollment.
Chris Macro: Thank you Tom.
Chris: Like to give a brief status update on our lead programs.
Chris: The FDA has granted our type D meeting requests regarding the empty <unk> study in locally advanced pancreatic cancer and according to their proposed timeline, we should have preliminary answers in late June.
Christopher McAleer: That aim and the F D. A R. An agreement we will then be able to move forward with expanding the patient population that would be eligible for enrollment.
Christopher McAleer: I will be able to speak further on this once we have a resolution from the Type D meeting. In the interim, there are open sites that are screening potential candidates, and we are also working to recruit an open new site.
Speaker Change: We'll be able to speak further on this once we have a resolution from the type D meeting in the interim there are open sites that are screening potential candidates and we're also working to recruit and opened new sites.
Christopher McAleer: Hopefully, upon successful consultation with the FDA, the revised protocol will allow for faster recruitment of sites and patients. The DORA-PANC study combining Ampligen and Dervalumab as therapy post-fulfuronox in metastatic pancreatic cancer is proceeding according to schedule. The phase one portion of the trial is a three and three escalation design with fixed Dervalumab doses and an escalating Ampligen dose. As we recently reported, the first three patients of the 3-in-3 design have completed the safety evaluation, and the few adverse events observed were only grade one with no serious adverse events. The Internal Evaluation Committee at Erasmus has approved the escalation to the next dose, and patients have already begun the evaluation and enrollment process. We expect the phase one portion of DoraPang to be completed this summer.
Speaker Change: Hopefully upon successful consultation with the FDA the revised protocol will allow for faster recruitment of sites and patients.
Speaker Change: The door pain study, combining ampligen and devalue mab as therapy post Fullfare, Nox and metastatic pancreas cancer is proceeding according to schedule. The phase one portion of the trial is a three and three escalation design with fixture value map dosing and escalating ampligen dose.
Speaker Change: As we recently reported the first three patients of the three and three design have completed the safety evaluation and the few adverse events observed were only grade one with no serious adverse events.
The internal evaluation committee at Erasmus has approved the escalation to the next dose and patients have already begun the evaluation and enrollment process. We expect the phase one portion of <unk> to be completed this summer.
Christopher McAleer: As promised, in the last update call, we announced the efficacy data of Ampligen, Pembrolizumab, and Cisplatin in the ongoing trial in advanced recurrent platinum-sensitive ovarian cancer at the University of Pittsburgh. The data indicated an objective response rate of 45%. When you compare this to the OOR or reject response rate of 39% in the preliminary data published in 2022 or the objective response rate of about 8% in the Keynote 100 study of Pember, Liz, and Mab alone, you can see the potential positive impact that this trial could have for women with recurrent ovarian cancer.
Speaker Change: As promised in our last update call, we have announced the efficacy data of Ampligen Pember Elysium map and cisplatin in the ongoing trial in advanced recurrent platinum sensitive ovarian cancer at the University of Pittsburgh. The data indicated an objective response rate of 45%. When you compare this to the O R or of that response rate.
Speaker Change: 39% in the preliminary data published in 2022 or the objective response rate of about 8% in the keynote 100 study a temporary lithium mab alone you can see the potential positive impact that this trial could have for women with recurrent ovarian cancer.
Christopher McAleer: We are currently working through the data for the ANT 518 trial for Ampligen as a potential therapy for the post-COVID condition of fatigue. We are also consulting with patient advocacy groups to further understand the symptomatology of patients to help further refine and design the follow-on trial. We are waiting for the results of the exploratory biomarker analysis to finalize the data, and as such, I do not currently have an estimate of when the next IND will be submitted, but we will keep stockholders and others informed as we proceed. And as you can see, we are advancing on our clinical agenda, and I look forward to being able to announce new progress throughout 2020. I'll hand it back to Tom to discuss the company financials.
Speaker Change: We are currently working through the data for the $5 18 trial for ampligen as a potential therapy for the post COVID-19 condition of fatigue.
Speaker Change: We are also consulting with patient advocacy groups to further understand the symptomatology of patients to help further refine and design. The follow on trial, we are waiting for the results of the exploratory biomarker analysis to finalize the data and as such I do not currently have an estimate of when the next <unk> will be submitted but we will keep.
Speaker Change: <unk> and others advised as we proceed.
Speaker Change: And as you can see we are advancing in our clinical agenda and I look forward to being able to announce new progress throughout 2024, and I'll hand, it back to Tom to discuss the company financials.
Tom: Thank you very much Chris.
Thomas K. Equels: Now for a brief summary of our first quarter financials. As you can see, the audit information is on the slide, but we share our operational and clinical execution with you. Now I want to touch on our financials so you can understand where we are in that respect. We ended the first quarter with $10.9 million. Our R&D expenses were consistent, while our G&A expenses were up from the same period. Importantly, we believe we have enough cash available to fund our operations through several key potentially value-driving milestones. Please take your time going through the full 10Q for a complete picture of the company's financials. Now,
Tom: Now for a brief summary of our first quarter financials.
Tom: As you can see the.
Tom: The oddity of information is on the slide.
Tom: But we share our operational and clinical execution with you now I want to touch on our financials. So you can understand where we are in that respect we ended the first quarter with $10 9 million.
Tom: Our R&D expenses were consistent while our G&A expenses were up from the same period last year.
Tom: Accordingly.
Tom: We believe we have enough cash available to fund our operations through several key potentially value driving milestones. Please take your time going through the full 10-Q for a complete picture of the company's financials.
No.
Thomas K. Equels: We believe very much in the depth, breadth, and potential of the amplitude, which provides a meaningful therapeutic solution in many high-value indications where there are high, even lethal, unmet medical needs. Our data continues to be highly encouraging, and it supports further development of our multiple ongoing studies as well as the next phase of development. Our success in the clinical trials leads us to believe that there will be a continuing developing body of positive safety and efficacy data.
Tom: We believe very much in the depth breadth.
Tom: And potential of ampligen.
Tom: To provide a meaningful therapeutic solution.
Tom: In many high value indications, where there are high even lethal unmet medical needs.
Speaker Change: Our data continues to be highly encouraging and it supports further development of our multiple ongoing studies as well as the next phase of development.
Speaker Change: Our success in the clinical trials leaves us to believe.
Speaker Change: There.
Speaker Change: Will be a continuing developing body a positive safety and efficacy data.
Thomas K. Equels: And we believe that data, because these are data-driven decisions, will help us to drive advanced discussions with potential commercial partners that are interested in the commercialization of Ampligen, especially in oncology. And finally, we believe all of our work and progress will ultimately unlock the full potential of Ampligen and AIM ImmunoTech as a value driver for investors and also as an important therapeutic solution for those suffering from these dreaded diseases. I very much appreciate your time, and we'll turn it back to the operator now for a question and answer session. Thank you.
Speaker Change: And we believe that data because these are data driven decisions.
Speaker Change: Help us to drive advanced discussions with potential commercial partners that are interested in the commercialization of ampligen, especially in oncology.
Speaker Change: And finally, we believe all of our work in progress will ultimately unlock the full potential of ampligen and aim of immune attack.
Speaker Change: The value driver for investors and also as an important therapeutic solution for those suffering from these dreaded diseases.
Speaker Change: I very much appreciate your time, and we'll turn it back to the operator now for a question and answer session.
Speaker Change: Thank you.
Operator: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you 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. Again, that's star 1 to register a question at this time. Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.
Speaker Change: Thank you. The floor is now opened for questions. If he would like to ask a question. Please press star one on your telephone keypad at this time a confirmation 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.
Speaker Change: Again, Thats Star one to register a question at this time.
Speaker Change: Today's first question is coming from Jason Mccarthy of Maxim Group. Please go ahead.
Chad: Hi guys, this is Chad speaking on behalf of Jason. Congratulations on the progress and thanks for taking the question. So firstly, for the interim ovarian readout, we were just wondering how many patients were evaluated. It would be helpful in, you know, comparing the data versus keynote, and also just general next steps for the program. Thanks. I believe, this is Tom. I believe approximately
Chad: Hi, guys. This is Chad on for Jason.
Speaker Change: Congrats on the progress and thanks for taking the question so.
Speaker Change: Firstly for the.
Speaker Change: On the interim ovarian readout.
Speaker Change: I'm just wondering how many patients were evaluated.
Speaker Change: It would be helpful in comparing the data versus keynote.
Speaker Change: And also just general next steps for the program. Thanks.
Thomas K. Equels: This is Tom. I believe approximately 27 subjects were evaluated. Chris might have the number in front of him here. There are 26 patients enrolled. The evaluation comes from 21 evaluable patients. Okay, thanks. Now, this is the interim report that's called for by the protocol, so there will be additional patients, but the data is extremely strong, indicating that Ampligen enhances the therapeutic impact of the cisplatin pembrolizumab program so significantly that we can see a very, very strong synergy from the combination of those.
Speaker Change: Chad.
Tom: I believe this is Tom I believe approximately 27 subjects were evaluated Chris might have the the number there in front of him here there are 26 patients enrolled.
Speaker Change: The evaluation comes from 21 Evaluable patients.
Speaker Change: Okay. Thank you.
Speaker Change: Yeah. No. This is the interim report that's called for by the protocol.
Speaker Change: So there will be additional patients, but the data is extremely strong indicating the ampligen.
Speaker Change: Enhances the therapeutic impact of the cisplatin Perm realism mab.
Speaker Change: Program.
So significantly that.
Speaker Change: We can see a very very strong.
Speaker Change:
Speaker Change: The synergy.
Speaker Change: From the combination of those drugs.
Chad: got it. Appreciate the How are you there?
Speaker Change: Got it.
Speaker Change: I appreciate the.
Chad: And then. Yeah, and in post COVID conditions, I mean, I know that that data again was very strong, and I was just wondering. I couldn't comment too much on next steps, but we can still expect that with that full study, data soon, and then. And that'll help inform the potential larger StatsIG-powered trial, is that right?
Speaker Change: Color there and then.
Speaker Change:
Speaker Change: Yeah and in post Covid conditions, I mean, I know that.
Speaker Change: That data again is very.
Speaker Change: Strong and I was.
Speaker Change: I was just wondering.
Speaker Change: I couldn't comment too much on next steps, but.
Speaker Change: We can still expect that the full study.
Speaker Change:
Speaker Change: Data soon and then.
Speaker Change: But that'll help inform the potential larger staffing.
Speaker Change: <unk> powered trial alright.
Christopher McAleer: That's correct. The data that has to be evaluated consists of tens of thousands of pages of information, so we're going through that now very carefully and rooting out any issues that flag signals as to where the parameters should be for inclusion data in our next step here. We kept the gate very wide in terms of inclusion for the study so that we could determine from onset of disease, severity of disease, and a number of different criteria where Ampligen works best in the treatment of long COVID or post-COVID exhibiting chronic fatigue-like conditions.
Speaker Change: That's correct.
Speaker Change: The data that has to be evaluated consists of tens of thousands of pages of information. So.
Speaker Change: We're going through that now very carefully and rooting out any.
Speaker Change: Any issues that flag cig.
Speaker Change: Signals as to you.
Speaker Change: You know where the parameters should be for inclusion data in our next step here.
Speaker Change: We kept the.
Speaker Change: Let's say the gate very wide in terms of inclusion for the study so that we can determine.
Speaker Change: Onset of disease severity of disease.
Speaker Change: A number of different criteria, where ampligen works best in the treatment of lung COVID-19 or post COVID-19.
Speaker Change: Exhibiting chronic fatigue like conditions, Chris do you have anything to add to that.
Christopher McAleer: The last piece that we need before we can proceed is exploratory biomarker analysis. I believe there will be data in there that helps pinpoint responders versus non-responders. And so that data we expect to have in the next three months or so. So, the generality of the inclusion criteria that we're looking to do, we're working with the Patient Advocacy Groups to get their input, as the FDA has requested, so that we can best monitor the symptoms of the patients, and when we combine that with the data we currently have on the exploratory biomarkers, I think we'll be prepared to launch the next trial, but that will take some time based on our waiting for the results of that
Speaker Change: And so the the last piece that we need before we can proceed as is the exploratory biomarker analysis I believe there will be data in there that helps.
Speaker Change: En pointe responders versus non responders.
Speaker Change: And so that data we expect to have in the next three months or so.
Speaker Change: So.
The generality of the inclusion criteria that we're looking to do we're working with the <unk>.
Speaker Change: Patient advocacy groups to get their input.
Speaker Change: The FDA has requested so that we can best monitor the symptoms of the patients and when we combine that with the data. We currently have an exploratory biomarkers I think will be.
Be prepared to launch the next trial, but that that will take some time based on our way waiting for the results of that.
Christopher McAleer: But this is one of those instances where haste makes waste. We did this so that we could have a very refined view of what the next trial should look like, which will make an effort to identify those persons with this syndrome most likely to respond to Ampligen as a therapeutic.
Speaker Change: But this is one of those instances where.
Speaker Change: Haste makes waste we did this so that we could have a very refined view of what the.
Speaker Change: Next trials should look like.
Speaker Change: Which will make.
Speaker Change: Make an effort to identify those persons with this syndrome, most likely to respond to ampligen as a therapeutic.
Chad: Got it, thanks. And then, just lastly, going back to the ovarian program, I know it's an ISP, but I guess what are your expectations in terms of a next step there after this, you know, positive interim data?
Speaker Change: Got it thanks, and then just lastly, going back to the ovarian program.
Speaker Change: I know, it's an I S T.
Speaker Change: I.
Speaker Change: I guess what are your expectations in terms of next steps are after this positive long term data.
Thomas K. Equels: Well, the data has an impact in a number of respects. This is a Phase II trial that was principally funded through a Merck grant. We supply the amplitude for the trial and, of course, technical assistance at our end, and it's an investigator-sponsored trial. When it's over, and we have the final publication of the investigators' reports related to the study, clearly, there's an opportunity to move forward. But we use this in combination with some of the other clinical trials where we've combined them so that we can see that that combination has the potential to be a powerful synergistic combination in a number of different solid tumors, which means that Ampligen's role, much like Pembrolizumab or Keytruda's role, is broad across the arena of solid tumors in oncology. So that's what we're working to prove long-term, and that's the kind of data that we hope to use as a part of our commercialization pitch to well-developed oncology companies that might have an interest in Ampligen.
Speaker Change: Well the the.
Speaker Change: The data has impact.
Speaker Change: In a number of respects.
Speaker Change: This is a phase.
Speaker Change: Phase III trial.
Speaker Change: It was principally funded through a Merck grant we supply the ampligen for the trial and of course, you know technical assistance at our end.
Speaker Change: And it's an investigator sponsored trial.
Speaker Change: When it's over and we are in the final publication of the investigators.
The reports are related to the study.
Speaker Change: Clearly there is an opportunity to move forward, but but we use this in combination with some of the other clinical trials, where we combine ampligen with member Luiza ma'am.
Speaker Change: So that we can see that that combination has the potential to be.
Speaker Change: A powerful synergistic combination in a number of different solid tumors, which means that ampligen roll much like pember Elysium Amber Keytruda as rule is broad spectrum across the arena of solid tumors in oncology.
Speaker Change: So that's what we're working to prove.
Speaker Change: Long term and that's the kind of data that we hope to use as a part of our commercialization pitch.
Speaker Change: Two well developed oncology companies that might have an interest in ampligen.
Thomas K. Equels: Okay, great. Thanks for taking the questions and congrats on all the progress. Well, thank you very much.
Speaker Change: Okay, great. Thanks.
Speaker Change: Thanks for taking my questions and congrats on all the progress.
Well, thank you very much.
Operator: Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.
Speaker Change: Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.
James Francis Molloy: Hey guys, thanks for taking my questions. I just had a question on your variety of ISTs ongoing, triple negative breast, metastatic colorectal, and prostate cancer. Can you, any sort of expectations for another outside of your control for near-term catalysts or potential catalysts upcoming on the broad range of ISTs you guys have ongoing?
James Francis Molloy: Hey, guys. Thanks for taking my questions I just had a question on you have a variety of I S. T is ongoing triple negative breast metastatic colorectal prostate cancer.
Speaker Change: Any any sort of expectations for another outside of your control.
Speaker Change: Near term catalysts or potential catalysts upcoming on the on the broad range of device changed you guys are ongoing.
Thomas K. Equels: As you mentioned, the good part about investigator-sponsored trials, and we've had a number of them that have advanced our position in oncology, is that they're typically funded by others, but they are also controlled by others in terms of the timing and the release of data. But thus far, you know, in all of these trials that we've done, the initial reports of data, and the publications, we have a host of publications now over the past two years that indicate that Ampligen has the potential to be a very powerful therapeutic agent in a wide range of tumors.
Speaker Change: Right.
Speaker Change: You mentioned the the good part about investigator sponsored trials and we've had a number of them that have advanced our position.
Speaker Change: Position in oncology.
Speaker Change: Is that they are they are typically funded by others, but they also are controlled by others in terms of the timing and the release of data and everything.
Speaker Change: But thus far as you know in all of these trials that we've done the initial.
Speaker Change: Reports of data in the publications, we have a host of publications now over the past two years.
Speaker Change: I did indicate that ampligen has the potential to be a very powerful thing.
Speaker Change: Therapeutic agent in a wide range of tumors.
Thomas K. Equels: So we look forward to the reports as these trials, these investigator-sponsored trials come to an end. Most of this information will probably be published in some form, either as an abstract or a peer-reviewed paper. We have a number of very strong peer-reviewed papers in extremely well-respected journals that are out there right now. If you go to our website, you can see a list of recent publications, probably over the past two and a half years.
Speaker Change: So we look forward to the reports.
Speaker Change: As these trials these investigator sponsored trials.
Speaker Change: Come to an end most of this information it will probably be published in some forum either as an abstract or a peer reviewed paper. We have a number of very strong peer reviewed papers and extremely well respected journals that are out there right. Now if you go to our website you can see a list of recent publications probably over the past two five.
Speaker Change: Five years.
Thomas K. Equels: So our feeling is very positive about the future of these trials, and it's instructive as to next steps because this is the kind of information that de-risks a major oncology trial, which can cost a very large amount.
Speaker Change: So our feeling is very positive about the future from these trials and it.
Speaker Change: Instructive.
Speaker Change: As to next steps because.
Speaker Change: This is the kind of information that de risks, our major oncology trial, which can cost.
Very large amounts of money.
James Francis Molloy: To follow-up on that, can you talk a little bit about the partnership environment, any thoughts on how that environment looks, and what potential partners for your variety of programs might be waiting on as you see it? I'm sorry, go ahead.
Speaker Change: It's not our.
Speaker Change: Follow up on that could you talk a little bit about how the partnership environment any any thoughts on how that environment looks and what are potential partners for a variety of programs might be waiting on.
Speaker Change: As you see it.
Speaker Change: I'm sorry go ahead.
James Francis Molloy: And if you could break it down between self-funding versus finding a partner to carry on some of these trials, obviously these are very expensive trials to run, what are your thoughts on that?
Just if you could break it down between self funding versus finding a partner to carry on some of these trials, obviously very expensive trials to run where your thoughts on that.
Thomas K. Equels: Well, our thought is that this is an opportune time to reach out. We've engaged a highly skilled B&D oncology group with Asanova. And we've targeted companies that we think may have an interest in what we're doing as a part of their strategic development. We have two major pharma companies that are involved in research combining Ampligen with their drug. We have a collaboration agreement, and if you go to our website, there's a press release from almost two years ago, I guess, related to the collaboration agreement we entered into with AstraZeneca.
Speaker Change: Okay.
Speaker Change: Our thought is that this is an opportune time to reach out.
Speaker Change: Engaged highly skilled BMD oncology.
Speaker Change: Group with Avenova.
Speaker Change: And we've targeted companies that we think that may have an interest in what we're doing as a part of their strategic development.
Speaker Change: Have to.
Speaker Change: Major pharma companies that are involved in research combining ampligen with their drug we have a collaboration agreement, which if you go to our website. There is a press release.
Speaker Change: Almost two years ago, I guess related to the collaboration agreement we entered into with Astrazeneca.
Thomas K. Equels: We also are moving forward in a number of investigator-sponsored trials with the assistance of Merck as a participant and named collaborator. And, for example, advanced recurrent ovarian cancer is probably the best example. So we have to presume that those companies are doing this because of some interest.
Speaker Change: We also are moving forward in a number of investigator sponsored trials with.
Speaker Change: With the assistance of <unk>.
Speaker Change: <unk> is a.
Speaker Change: As a participant in.
Speaker Change: Named collaborator.
Speaker Change: And for example in advanced recurrent ovarian cancer is probably the best example, so so.
Speaker Change: We have to presume that those companies are doing this because of some interest in and there are other companies that this might enhance.
Speaker Change: Especially those companies with.
Speaker Change: Underperforming.
Speaker Change: Checkpoint inhibitor drugs might enhance their overall picture by creating a boosting efficacy down the road.
Speaker Change: Through a combination therapy.
Thomas K. Equels: And there are other companies that this might enhance, especially those companies with underperforming checkpoint inhibitor drugs might enhance their overall picture by creating a boost in efficacy down the road through combination therapy. Also, we recently had a US patent issued for our combination therapy synergistic approach with Ampligen, combining it with PD-L1 checkpoint inhibitors. A little over a year and a half ago, my timing may be off, this is off the top of my head, we started to receive approvals of our general synergistic patent approach for Ampligen with checkpoint inhibitors generally. And we're looking to create patent protection for Ampligen with PD-L1 type checkpoint inhibitors.
Speaker Change: Also we recently.
Speaker Change: Adding a U S patent issued for our combination therapy synergistic approach with ampligen, combining it with PDL one checkpoint inhibitors.
Speaker Change: A little over a year and a half ago My timing maybe office is off the top of my head.
We started to receive.
Speaker Change: <unk> General synergistic patent approach for ampligen with checkpoint inhibitors generally.
Speaker Change: And we're looking to.
Speaker Change: Create patent protection with Ampligen with PD, one type checkpoint inhibitors as well.
James Francis Molloy: Oh great, thank you for taking my question.
Speaker Change: Oh, great. Thanks for taking my questions.
Speaker Change: Well thank you Jim.
Operator: Thank you. The next question is coming from Ed Woo of Ascendian Capital Markets. Please go ahead.
Speaker Change: Thank you. The next question is coming from Ed Woo of <unk> capital markets. Please go ahead.
Edward Moon Woo: Yeah, congratulations on all the progress. My question is about the recent manufacturing of Ampligen. How difficult or easy was it compared to the last batch you did? And in terms of also, was there any difference in the cost and your outlook for producing more going forward? Thank you.
Edward Moon Woo: Yes, congratulations on all the progress my question is on the recent manufacturing absolute gem.
Edward Moon Woo: Much difficult or easy was a compare to the last batch that and in terms of also or was there any difference in the cost.
Speaker Change: And your outlook for producing walk going forward. Thank you.
Thomas K. Equels: Thank you, Dr. Woo. The recent manufacturing process went well. We aren't there to watch it, so, you know, all I can say is there were no reports of problems or anything like that. The costs, like everything, especially in this medical R&D space, have all increased over time. But we see that in our clinical trials, everything is significantly more expensive than it was five years ago. Does that answer your question, Ed?
Speaker Change: Thank you Dr <unk>.
Speaker Change: The recent manufacturer recent manufacturing process went well.
Speaker Change:
Speaker Change: We arent.
There to watch it.
Speaker Change: So all I can say is there were no no reports of problems or anything like that.
Speaker Change: Because we use a contract with a well established contract manufacturer that has worked for us over over several years Thats jubilant Hollister steer there.
Speaker Change: In Spokane, Washington.
Speaker Change:
Speaker Change: The the.
Speaker Change: The cost like the like much especially in this.
The medical arm.
Speaker Change: Randy space.
Speaker Change:
Speaker Change: Have all increased over time.
Speaker Change: But we.
Speaker Change: We see that in our clinical trials that everything is significantly more expensive than it was five years ago.
Speaker Change: Does that answer your question.
Edward Moon Woo: Yes, yes it does. And do you anticipate that if you do need another batch that it will be a similar process?
Speaker Change: Yes, yes, it does and it do you anticipate if you do need another patch that it will be the similar process.
Thomas K. Equels: Well, we're anticipating that in the next two years, we probably won't need another one. But one of the reasons we did this is to make sure that we had adequate reserves, not just for what we're doing but for future activities. However, if we were to launch a, you know, large-scale oncology trial, say for new drug approval purposes with a commercial partner, there would be a need to manufacture more ampligen. We believe this is a reproducible, repeatable process that we've been using.
Speaker Change: Well, we're anticipating that in the next few years, we probably don't need another about one of the reasons. We did this is to make sure that we had adequate reserves not just for what we're doing but for future activity. However, if we were to launch into a large scale oncology trials.
Speaker Change: For new drug approval purposes, with with a commercial partner there would be a need to manufacture.
Speaker Change: More ampligen.
Speaker Change: We believe this is a reproducible repeatable process that we've been using and we're doing work on manufacturing processes.
Thomas K. Equels: And we're doing work on manufacturing processes from start to finish, including all the components that go into ampligen, so as to create an efficient, reproducible, and cost-effective approach to ampligen manufacture. And when we manufacture commercial lots, because these are smaller lots, it's..., you know, very expensive. But mass produced ampligen has the potential to be manufactured at a much lower cost than what we're seeing right now.
Speaker Change: <unk> start to finish and including all the components.
Speaker Change: That go into ampligen, so as to.
Speaker Change: Create a.
Speaker Change: Efficient.
Speaker Change: Reproducible and.
Speaker Change: Cost effective approach to the EM ampligen manufacturing.
Speaker Change: When we manufacture commercial lines because these are smaller lines.
Speaker Change: <unk>.
Speaker Change: Very expensive.
Speaker Change: But.
Speaker Change: Mass produced ampligen has the potential.
Speaker Change: To be manufactured at much lower cost than what we're seeing right now.
Edward Moon Woo: Great. Well, thanks for answering my questions, and I wish you good luck. Thank you.
Speaker Change: Great well, thanks for answering my questions and I wish you. Good luck. Thank you.
Speaker Change: Well thank you.
Operator: Thank you. This brings us to the end of the question and answer session. I would like to turn the floor back over to Mr. Equals for closing comments.
Speaker Change: Thank you this brings us to the end of the question and answer session I would like to turn the floor back over to Mr. Equals for closing comments.
Thomas K. Equels: Well, thank you very much, Operator, and I want to thank all of the analysts that participated today in the question and answer session. We at AIM ImmunoTech are very pleased with the progress that we're making, and our hopes for the future are high. We also appreciate the support that we've had from shareholders, the investment community, and we look forward to serving them well, as well as what is our most important stakeholder population, these people who are suffering from lethal Unmet medical needs and oncology, where we can see a real opportunity to make a difference. You know, our motto is Immunology for a Better Future, and we strive to create that future today.
Thomas K. Equels: Well, thank you very much operator, and I want to thank all of the analysts.
Thomas K. Equels: Participating today in the question and answer session.
Thomas K. Equels: <unk>.
Speaker Change: We at AME immune attack.
Speaker Change: Very pleased with the progress that we're making.
Speaker Change: Our hopes for the future of high.
Speaker Change: We also appreciate the support that we've had.
Speaker Change: From shareholders the investment community.
Speaker Change: And we look forward to serving them well as well as what is our most important.
Speaker Change:
Speaker Change: Stakeholder population. These people who are suffering from lethal unmet medical needs in oncology, where we can see a real opportunity to make a difference.
Speaker Change: Motto is immunology for a better future and we strive to create that future today.
Operator: Ladies and gentlemen, 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.
Speaker Change: Ladies and gentlemen, thank you for your interest in <unk> immune attack. 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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Speaker Change: Okay.
Speaker Change: [music].