Q2 2024 AIM ImmunoTech Inc Earnings Call

August 16, 2024

Speaker Change: The End

Jason Mccarthy: Jason McCarthy, Edward Woo, James Molloy, Jenene Thomas. Hello and welcome to the AIM ImmunoTech Second Quarter 2024 update conference calling webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance or an event, please press star zero on your telephone keypad. Follow the presentation; there'll 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.

Speaker Change: Don't forget to subscribe... until next time ... Goodbye

Unknown Executive: In the next episode, we'll see you in the next episode, and we'll see you in the next episode. Jason McCarthy, Edward Woo, James Molloy, Jenene Thomas, Jason McCarthy, Edward Woo, James Molloy, Jason McCarthy, Edward Woo, James Molloy, Jenene Thomas, Hello and welcome to the AIM ImmunoTech second 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 the event, please press star zero on your telephone keypad.

Speaker Change: Hello and welcome to the AIM Immunotech second quarter 2024 update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode.

Speaker Change: If anyone requires operator assistance during an event, please press star zero on your telephone keypad.

Unknown Executive: 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. 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 uncertainties. Forward looking statements on 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. As a result, you should not place under-reliance on any forward-looking statements.

Speaker Change: 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.

Unknown Executive: At this time of lecture, reminder 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 uncertainties. Forward-looking statements on 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. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports in ImmunoTech files, which is carried in exchange commission.

Unknown Executive: Some of the factors that could cause actual results differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports in ImmunoTech files with the Securities and Exchange Commission. These documents are available in the investment section of the company's website and on the Securities and Exchange Commission's website. We encourage you to view 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 management's intentions, beliefs, expectations, or future projections.

Speaker Change: These are forward-looking statements and involve risks and uncertainties.

Aim Aminotech: Forward looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on Aim Aminotech's current expectations and actual results could differ materially.

Aim Aminotech: As a result, you should not place under-reliance on any forward-looking statements.

Aim Aminotech: Some of the factors that could cause actual results differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports in Munotech files with the Securities and Exchange Commission.

Unknown Executive: 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 view these documents carefully.

Aim Aminotech: These documents are available in the investor section of the company's website and on the Securities and Exchange Commission's website.

Unknown Executive: Additionally, certain information contained in this webcast relates to or is based on studies, on studies, publication surveys, and other data obtained from third-party sources and the company's own estimates and research. While the company believes third-party sources to be reliable as of the day of this presentation, it is not independently verified and makes no representation as to the advocacy, fairness, accuracy, or completeness of, or that any independent source has verified any information obtained from third-party sources.

Aim Aminotech: We encourage you to view these documents carefully.

Aim Aminotech: Additionally, certain information contained in this webcast relates to or is based on a study's publication, surveys, and other data obtained from third-party sources and the company's own estimates and research.

Unknown Executive: While the company believes third-party sources to be reliable as of the date of this presentation, it is 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.

Aim Aminotech: Well, the company believes third-party sources to be reliable as of the day of this presentation.

Aim Aminotech: It is not independently verified and makes no representation as to the adequacy, fairness, accuracy...

Speaker Change: or completeness of or that any independent source has verified any information obtained from third-party sources. Joining us on today's call from the Amamunotech leadership team are Thomas Equels, Chief Executive Officer and Christopher McAleer, Ph.D. Scientific Officer.

Unknown Executive: Joining us on today's call from the AIM ImmunoTech leadership team are Thomas Equals, Chief Executive Officer, and Christopher McLear, PhD, Scientific Officer.

Unknown Executive: Joining us on today's call from the AIM ImmunoTech leadership team are Thomas Equels, Chief Executive Officer, and Christopher McAleer, Ph. D., Scientific Officer. I now turn the conference call over to Tom Equels, CEO. Please proceed.

Thomas Equels: I now let's turn the conference call over to Tom Equals, CEO. Please proceed.

Speaker Change: I now turn the conference call over to Tom Equels, CEO. Please proceed.

Thomas Equels: Thank you, operator, to get started. I'd like to say that I cannot be more proud, not just of our team at AIM, but of our key clinical partners at top cancer research centers for their hard work and continued focus on execution of clinical trials demonstrating Ampligence potential. Over the past quarter, we have been working diligently to advance the Amplogen across all of our development programs. Of note, over the past quarter, we continue to generate data that demonstrates the potential of Amplogen in oncology.

Thomas Equels: Thank you, operator, to get started. I'd like to say that I cannot be more proud, not just of our team at AIM, but of our key clinical partners at Top Cancer Research Center, for their hard work and continued focus on execution of clinical trials demonstrating Ampligen's potential. Over the past quarter, we have been working diligently to advance the Ampligen across all of our development programs. Of note, over the past quarter, we continue to generate data that demonstrates the potential of ampligen in oncology. These new positive data showed that in combination with dendritic cell vaccines, including anti-PD-1, PD-L1 checkpoint inhibitors. Ampligen slowed tumor growth with improved survival in a preclinical model.

Tom Equels: Thank you, Operator. To get started, I'd like to say that I cannot be more proud, not just of our team at AIM.

Tom Equels: but of our key clinical partners at top cancer research centers.

Tom Equels: for their hard work and continued focus on execution of clinical trials demonstrating Ampligen's potential.

Tom Equels: Over the past quarter we have been working diligently to advance the Ampligen across all of our development programs.

Tom Equels: Of note, over the past quarter, we continue to generate data that demonstrates the potential of ampligen in oncology.

Thomas Equels: These new positive data showed that, in combination with dendritic cell vaccines, including anti-PD1, PDL1 checkpoint inhibitors, Amplogen slowed tumor growth with improved survival in a preclinical model. This encouraging data was published in the prestigious peer-reviewed journal Vaccine.

Tom Equels: These new positive data showed that in combination with dendritic cell vaccines, including anti PD-1, PD-L1 checkpoint inhibitors.

Tom Equels: Ampligen slowed tumor growth with improved survival in a preclinical model. This encouraging data was published in the prestigious peer-reviewed journal, Vaccines.

Thomas Equels: This encouraging data was published in the prestigious peer-reviewed journal Vaccines. While preclinical, these data do give us confidence as we advance our active, ongoing clinical oncology programs in pancreatic and ovarian cancer. I'd also like to point everyone toward our last quarterly update call in May, which because of timing covered many of our accomplishments in the second quarter. Those included updates in both our pancreatic cancer and ovarian cancer work, as well as the GMP manufacturer of approximately 9,000 clinical vials of Ampligen.

Thomas Equels: While preclinical, these data do give us confidence as we advance our active, ongoing clinical oncology programs in pancreatic and ovarian cancer.

Tom Equels: While preclinical, these data do give us confidence as we advance our active, ongoing clinical oncology programs in pancreatic and ovarian cancer.

Thomas Equels: I'd also like to point everyone toward our last quarterly update, Colin May, which, because of timing, covered many of our accomplishments in the second quarter. Those included updates in both our pancreatic cancer and ovarian cancer work, as well as the GMP manufacturer of approximately 9,000 clinical valves of Amplition.

Tom Equels: I'd also like to point everyone toward our last quarterly update call in May, which because of timing covered many of our accomplishments in the second quarter.

Tom Equels: Those included updates in both our pancreatic cancer and ovarian cancer work, as well as the GMP manufacture of approximately 9,000 clinical vials of Ampligen.

Thomas Equels: Additionally, earlier this year, we made a commitment to all of our stakeholders that transparency would be at the forefront of what we do. We believe we are holding true to this commitment and continue to be active on the CEO Corner program, which we launched earlier this year. Through this platform, which can be found on our website and posted on social media, we strive to provide information and access. And I invite all of you to go to the CEO Corner on our website, sign up for the alerts, and also submit topics of interest that you would like us to cover.

Thomas Equels: Additionally, earlier this year we made a commitment to all of our stakeholders that transparency would be at the forefront of what we do. We believe we are holding true to this commitment and continue to be active on the CEO Corner program which we launched earlier this year. Through this platform, which can be found on our website and posted on social media, we strive to provide information and access.

Tom Equels: Additionally, earlier this year, we made a commitment to all of our stakeholders

Tom Equels: the transparency would be at the forefront of what we do.

Tom Equels: We believe we are holding true to this commitment.

Tom Equels: and continue to be active on the CEO Corner program, which we launched earlier this year. Through this platform, which can be found on our website and posted on social media,

Thomas Equels: And I invite all of you to go to the CEO Corner on our website, sign up for the alerts, and also submit topics of interest that you would like us to cover. Now, to go into the details of our recent clinical advancements, I'd like to turn this call over to our science officer, Dr. Chris McAleer. Thank you, Tom.

Tom Equels: We strive to provide information and access. And I invite all of you to go to the CEO corner on our website, sign up for the alerts, and also submit topics of interest that you would like us to cover.

Christopher McAleer: Now, to go into the details of our recent clinical advancements, I'd like to turn this call over to our science officer, Dr. Chris McAleer. Thank you, Tom. I will give a brief overview of the clinical status of our priority development program, and I'll start with DoraPank. DoraPank is a phase one, two trial to determine the safety and efficacy of combining ampligen with AstraZeneca's devaluemab in the treatment of metastatic pancreas cancer. We announced recently that the first cohort of the dose escalation had completed the safety evaluation, and the medical review committee agreed to move forward with the next dosing level.

Speaker Change: Now, to go into the details of our recent clinical advancements, I'd like to turn this call over to our science officer, Dr. Chris McAleer.

Christopher McAleer: I will give a brief overview of the clinical status of our priority development programs, and I'll start with door. Doropank is a Phase I-II trial to determine the safety and efficacy of combining Ampligen with AstraZeneca's Divalumab in the treatment of metastatic pancreas. We announced recently that the first cohort of the dose escalation had completed the safety evaluation and the medical review committee agreed to move forward with the next dose. The three patients to be evaluated in the second grouping of the 3-in-3 design have since finished the safety evaluation, and this dose level was also deemed safe. Additional patients are being enrolled at this highest dose level, which is 1,500 milligrams Tervalumab and 400 milligram Ampligen.

Chris McAleer: Thank you, Tom. I will give a brief overview of the clinical status of our priority development programs and I'll start with DORPANG.

Christopher McAleer: And these are the last three patients of the phase one portion. And together with the other three already receiving this dose, will be included as the first patients of the phase two efficacy evaluation. The first patients of the initial 200 milligram dose level are reaching the next efficacy evaluation, which is set for week 24.

Speaker Change: Doropank is a phase 1-2 trial to determine the safety and efficacy of combining Ampligen with AstraZeneca's jivalumab in the treatment of metastatic pancreas cancer.

Speaker Change: We announced recently that the first cohort of the dose escalation had completed the safety evaluation and the Medical Review Committee agreed to move forward with the next dosing level.

Christopher McAleer: The three patients to be evaluated in the second grouping of the three and three design have since finished the safety evaluation, and this dose level was also deemed safe. Additional patients are being enrolled at this highest dose level, which is 1,500 milligrams Devaluemab and 400 milligrams Ampligen. And these are the last three patients of the phase one portion. And together with the other three already receiving this dose, will be included as the first patients of the phase two efficacy evaluation. The first patients of the initial 200 milligram dose level are reaching the next efficacy evaluation, which is set for week 24.

Speaker Change: The three patients to be evaluated in the second grouping of the 3-in-3 design has since finished the safety evaluation and this dose level was also deemed safe.

Speaker Change: Additional patients are being enrolled at this highest dose level, which is 1,500 milligrams Tervalumab and 400 milligram Ampligen, and these are the last three patients of the Phase 1 portion, and together with the other three already receiving this dose, will be included as the first patients of the Phase 2 efficacy evaluation.

Speaker Change: The first patients of the initial 200 milligram dose level are reaching the next efficacy evaluation, which is set for week 24. And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12, and the first patient...

Christopher McAleer: And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12. And the first patient continues to have stable disease at week 24. And while this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression-free survival we saw with ampligen alone in the EAP conducted at Erasmus. And this has us excited. And as of our last update earlier this week, two of those patients still have stable disease. And we are hopeful that we will see responses from these patients even at that lower Ampligen dose.

Christopher McAleer: And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12, and the first patient, continues to have stable disease at week 24. And while this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression-free survival we saw with Ampligen alone in the EAP conducted at ERAP. And this has us excited.

Speaker Change: continues to have stable disease at week 24.

Speaker Change: And while this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression-free survival we saw with Ampligen alone in the EAP conducted at Erasmus.

Christopher McAleer: And as of our last update earlier this week, two of those patients still have stable. And we are hopeful that we will see responses from these patients, even at that lower ampligen dose. The time to response of immunotherapies is in the weeks to months range, depending on the tumor type. And also, we expect the response to be slower than might be seen in other tumor types based on the fact that pancreatic tumors have a thick, fibrous, desmoplastic nature, which makes immune infiltration more difficult.

Speaker Change: and this has us excited. And as of our last update earlier this week, two of those patients still have stable disease.

Speaker Change: And we are hopeful that we will see responses from these patients, even at that lower ampligen dose.

Christopher McAleer: The time to response of immunotherapies is in the weeks to month range, depending on the tumor type. And also, we expect the response to be slower than might be seen in other tumor types based on the fact that pancreatic tumors have a thick, fibrous, desmoplastic nature, which makes immune infiltration more difficult.

Speaker Change: And the time to response of immunotherapies is in the weeks to months range depending on the tumor type

Speaker Change: And also, we expect the response to be slower than might be seen in other tumor types, based on the fact that pancreatic tumors have a thick, fibrous, desmoplastic nature, which makes immune infiltration more difficult.

Christopher McAleer: Medical. And so that is where we stand with our clinical progress and metastatic pancreas cancer.

Christopher McAleer: And so that is where we stand with our clinical progress in metastatic pancreas cancer. But in regards to our work in locally advanced pancreas cancer, we have received the FDA's written response to our Type D meeting package in June. The FDA has agreed in principle with our proposed changes to the inclusion criteria and treatment arms. And we are working on finalizing approval of the protocol changes.

Christopher McAleer: But in regards to our work in local advanced pancreas cancer, we have received the FDA's written response to our Type D meeting package in June. The FDA has agreed in principle with our proposed changes to the inclusion criteria and treatment arms, and we are working on finalizing approval of the protocol changes. While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different U.S. institutions. So it is important that the trial be managed so as to maximize the usefulness of the data we receive while keeping trial costs within reason.

Speaker Change: And so that is where we stand with our clinical progress in metastatic pancreas cancer.

Speaker Change: But in regards to our work in locally advanced pancreas cancer, we have received the FDA's written response to our type D meeting package in June.

Speaker Change: The FDA has agreed in principle with our proposed changes to the inclusion criteria and treatment arms, and we are working on finalizing approval of the protocol changes.

Christopher McAleer: While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different U.S. institutions, so it is important that the trial be managed so as to maximize the usefulness of the data we receive while keeping trial costs within reason. And this is especially important when it comes time to consider future steps in the development of a treatment. When we have full regulatory go ahead to proceed, we believe this new protocol will allow for greater site and patient recruitment in the U.S. Our last oncology update relates to the Advanced Recurrent Ovarian Cancer Trial using Ampligen plus Pembrolizumab and Cisplatin in platinum-sensitive ovarian cancer. Based on conversations with Dr. Robert Edwards at the University of Pittsburgh, we know that the results thus far are better than he had expected.

Speaker Change: While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different U.S. institutions, so it is important that the trial be managed so as to maximize the usefulness of the data we receive while keeping trial costs within reason.

Christopher McAleer: And this is especially important when it comes time to consider future steps in the development of a treatment. When we have full regulatory go-ahead to proceed, we believe this new protocol will allow for greater sight and patient recruitment in the U.S.

Speaker Change: And this is especially important when it comes time to consider future steps in the development of a treatment.

Speaker Change: When we have full regulatory go ahead to proceed, we believe this new protocol will allow for greater site and patient recruitment in the U.S.

Christopher McAleer: Our last oncology update relates to the advanced recurrent ovarian cancer trial using Amplogen plus Pembrolysmab and Sysplatin in platinum-sensitive ovarian cancer. Based on conversations with Dr. Robert Edwards at the University of Pittsburgh, we know that the results thus far are better than he had expected, and patients have seen a clinical benefit rate of greater than 60%. In addition, he was also quite impressed with the immune changes to the tumor microenvironment, and the trial was proceeding so well that he feels there is no need to enroll the total 45 patients as originally planned. And therefore, the trial is wrapping up enrollment, and future steps are being planned, and you should see manuscripts highlighting the data coming from the University of Pittsburgh as early as the end of the year.

Speaker Change: Our last oncology update relates to the advanced recurrent ovarian cancer trial using Ampligen plus Pembrolizumab and Cisplatin in platinum-sensitive ovarian cancer.

Christopher McAleer: And patients have seen a clinical benefit rate of greater than 60 percent. In addition, he was also quite impressed with the immune changes to the tumor microenvironment, and the trial was proceeding so well that he feels there is no need to enroll the total 45 patients, as originally planned, and therefore the trial is wrapping up enrollment and future steps are being planned, and you should see manuscripts highlighting the data coming from the University of Pittsburgh as early as the end of the year.

Robert Edwards: Based on conversations with Dr. Robert Edwards at the University of Pittsburgh, we know that the results thus far are better than he had expected, and patients have seen a clinical benefit rate of greater than 60 percent.

Speaker Change: In addition, he was also quite impressed with the immune changes to the tumor microenvironment, and the trial was proceeding so well that he feels there is no need to enroll the total 45 patients.

Speaker Change: as originally planned and therefore the trial is wrapping up enrollment and future steps are being planned and you should see manuscripts highlighting the data coming from the University of Pittsburgh as early as the end of the year.

Christopher McAleer: As great as the initial response data is, I am personally the most interested in seeing the follow-up data with the duration of response. As you know, chemotherapy regimens have been effective in generating response data in these patients, but unfortunately for those who are afflicted, the sad reality is a variant cancer notoriously comes back with a recurrence rate of approximately 80% for stages 3 and 4 patients. We believe the immune modulating properties of this treatment and amplogens' potential to modulate the immune milieu of the tumor microenvironment might help in this regard. And we are also eager to see preliminary data in the Phase II study of advanced recurrent ovarian cancer, combining the amplogen containing chemokine modulation therapy with the splatten and a dendritic cell vaccine, which is now open for recruitment.

Speaker Change: As great as the initial response data is, I am personally the most interested in seeing the follow-up data with the duration of response.

Speaker Change: As you know, chemotherapy regimens have been effective in generating response data in these patients.

Speaker Change: But unfortunately for those who are afflicted, the sad reality is ovarian cancer notoriously comes back with a recurrence rate of approximately 80% for stages 3 and 4 patients.

Christopher McAleer: We believe the immune modulating properties of this treatment and Ampligen's potential to modulate the immune milieu of the tumor microenvironment might help in this regard. And we are also eager to see preliminary data in the phase two study of advanced recurrent ovarian cancer, combining the Ampligen-containing chemokine modulation therapy with cisplatin and a dendritic cell vaccine, which is now open for request. And lastly, I want to update you on the progress of Ampligen for the post COVID condition of, We have done a thorough analysis of the data, and we have identified certain inclusion criteria that can help delineate the high response.

Speaker Change: We believe the immune modulating properties of this treatment and Ampligen's potential to modulate the immune milieu of the tumor micro environment might help in this regard.

Speaker Change: And we are also eager to see preliminary data in the Phase 2 study of advanced recurrent ovarian cancer combining the Ampligen-containing chemokine modulation therapy with Cisplatin and a dendritic cell vaccine, which is now open for recruitment.

Christopher McAleer: And lastly, I want to update you on the progress of amplogen for the post-COVID condition of fatigue. We have done a thorough analysis of the data, and we have identified certain inclusion criteria that can help delineate the high responders. We are awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September. We have also been working with patient advocacy groups to better understand the patient journey and solicited their input on the subsequent trial design. While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial.

Speaker Change: And lastly, I want to update you on the progress of Ampligen for the post-COVID condition of fatigue.

Speaker Change: We have done a thorough analysis of the data and we have identified certain inclusion criteria that can help delineate the high responders.

Speaker Change: We are awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September.

Speaker Change: We have also been working with patient advocacy groups to better understand the patient journey and solicited their input on the subsequent trial design.

Christopher McAleer: While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial. We are drafting a preliminary regulatory package that we aim to submit to the FDA in Q4. And that is a brief overview of our priority clinical pipeline, and I'll hand it back to Tom to discuss the company financials. Good job. Thank you very much, Chris.

Speaker Change: While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial. We are drafting a preliminary regulatory package that we aim to submit to the FDA in Q4.

Christopher McAleer: We are drafting a preliminary regulatory package that we aim to submit to the FDA in Q4.

Christopher McAleer: And that is a brief overview of our priority clinical pipeline, and I'll hand it back to Tom to discuss the company financials. Good job. Thank you very much, Chris.

Speaker Change: And that is a brief overview of our priority clinical pipeline, and I'll hand it back to Tom to discuss the company financials. Good job. Thank you very much, Chris.

Thomas Equels: Now I'd like to go into the financial picture. For those of you familiar with the micro-cap biotech sector, it's a rough area over the past couple of years. But we are fortunate that we can announce that we have a cash position, which we believe is sufficient to fund operations through multiple key milestones that are coming up. Our cash equivalents and marketable securities are $10.1 million as of June 30, 2024. Our research and development expenses for the three months and six months ending in June 30, 2024, were 1.1 million and 3.1 million, respectively. And that's compared to 3 million and 5 million for the same period of 2023.

Thomas Equels: Now, I'd like to go into the financial picture. For those of you familiar with the microcap biotech sector, it's a rough area over the past couple of years. But we are fortunate that we can announce that we have cash position, which we believe sufficient to fund operations through multiple key milestones that are coming up. Our cash, cash equivalents, and marketable securities are $10.1 million as of June 30, 2024. Our research and development expenses for the three months and six months ending in June 30, 2024, were $1.1 million and $3.1 million, respectively.

Tom Equels: Now I'd like to go into the financial picture.

Tom Equels: For those of you familiar with the microcap biotech sector, it's a rough area over the past couple of years. But we are fortunate that we can announce that we have cash position, which we believe sufficient to fund operations through multiple key milestones that are coming up.

Thomas Equels: And that's compared to $3 million and $5 million for the same period of 2023. General and administrative expenses for the three months and six months that ended June 30, 2024 were $2.6 million and $6.4 million, respectively, compared to $2.6 million and $4.8 million for the same period of 2023.

Tom Equels: Our cash, cash equivalents, and marketable securities are $10.1 million as of June 30, 2024.

Tom Equels: Our research and development expenses for the three months and six months ending in June 30, 2024, were $1.1 million and $3.1 million, respectively. And that's compared to $3 million and $5 million for the same period of 2023.

Thomas Equels: General and administrative expenses for the three months and six months that ended June 30, 2024 were 2.6 million and 6.4 million, respectively, compared to 2.6 million and 4.8 million for the same period of 2023.

Tom Equels: General and administrative expenses for the three months and six months that ended June 30, 2024 were $2.6 million and $6.4 million, respectively, compared to $2.6 million and $4.8 million for the same period of 2023.

Thomas Equels: Now, as we reflect on our progress and the data is what tells the story of the progress that we've made over the past couple of years. You'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for Amplition. And we are not only excited for the future of the company, but we believe that Amplition has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors, but the patient populations that we hope to serve also.

Thomas Equels: Now, as we reflect on our progress, And the data is what tells the story of the progress that we've made over the past couple of years. You'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for amplitude. And we are not only excited for the future of the company, but we believe that Ampligen has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors, but the patient populations that we hope to serve also. And when you look at our company, you may ask, well, why AIM? Why now?

Tom Equels: Now, as we reflect on our progress,

Tom Equels: And the data is what tells the story of the progress that we've made over the past couple years.

Speaker Change: You'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for Ampligen.

Speaker Change: and...

Speaker Change: We are not only excited for the future of the company, but we believe that Ampligen has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors.

Thomas Equels: And when you look at our company, you may ask, well, why Am, why now? The reason is we have encouraging data that drives our programs. We have multiple ongoing clinical studies at top cancer research institutions. And with regard to two of these studies, we are collaborating with big pharma companies. For example, the Advanced Recurrent Ovarian Cancer Study at Pitt. If you look at the ClinicalTrials.gov filing with Merck and Erasmus in the Netherlands, our DuraPank study is in collaboration with AstraZeneca. So we have all the ingredients we believe for a bright future.

Speaker Change: but the patient populations that we hope to serve also.

Speaker Change: When you look at our company, you may ask, well, why AIM? Why now?

Thomas Equels: The reason is we have encouraging data, that drives our programs. We have multiple ongoing clinical studies at top cancer research institutions. And with regard to two of these studies, we are collaborating with big pharma companies. For example, the Advanced Recurrent Ovarian Cancer study at Pitt. We collaborate, if you look at the clinicaltrials.gov filing, with Merck. And in Erasmus in the Netherlands, our DuraPanc study is in collaboration with AstraZeneca.

Speaker Change: The reason is we have encouraging data.

Speaker Change: that drives our programs. We have multiple ongoing clinical studies at top cancer research institutions.

Speaker Change: And, with regard to two of these studies, we are collaborating

Speaker Change: with big pharma companies, for example, the Advanced Recurrent Ovarian Cancer Study at Pitt.

Speaker Change: We collaborate, if you look at the clinicaltrials.gov filing, with Merck and in Erasmus in the Netherlands. Our Durapanc study is in collaboration with AstraZeneca.

Thomas Equels: So we have all the ingredients, we believe, for a bright future. Thank you very much everybody for your interest. At this point, I'd like to open up the floor for questions. Operator?

Speaker Change: So we have all the ingredients, we believe, for a bright future.

Thomas Equels: Thank you very much, everybody, for your interest.

Unknown Executive: At this point, I'd like to open up the floor for questions.

Speaker Change: Thank you very much, everybody, for your interest. At this point, I'd like to open up the floor for questions. Operator?

Unknown Executive: Operator?

Operator: Thank you. We're now conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove a question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. Once again, if you would like to be placed into question queue at this time, please press star 1 on your telephone keypad.

Unknown Executive: Thank you. And now that you're dumping 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 a question from the queue. For participants using speaker equipment and maybe necessary to pick up your handset before pressing star one. Once again, if you'd like to be placed in the question queue at this time, please press star one on your telephone keypad. One moment, please, while we pull for questions.

Speaker Change: Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker Change: You may press star 2 if you'd like to remove a question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1.

Speaker Change: Once again, if you'd like to be placed into question queue at this time, please press star 1 on your telephone keypad. One moment please, while we poll for questions.

Operator: One moment please while we poll for questions. And we've reached the end of our question and answer session, and at this point I'd like to turn the floor back over for any further closing comments. Again, I just want to thank everybody for their interest, and we're working very hard to fulfill AIM's motto, immunology for a better future. Thank you very much. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have

Thomas Equels: We reshed of our question and intercession, and at this point I would turn the floor back over for any further closing comments. Again, I just want to thank everybody for their interest, and we're working very hard to fulfill AIM's motto: immunology for a better future.

Speaker Change: We've reached the end of our question and answer session. At this point, I'd like to turn the floor back over for any further closing comments.

Speaker Change: Again, I just want to thank everybody for their interest, and we're working very hard to fulfill AIM's motto, immunology for a better future. Thank you very much.

Unknown Executive: Thank you very much.

Unknown Executive: Thank you, that does conclude today's telecompressor webcast, and we just connect to AIM at this time. Have a wonderful day. We thank you for your participation today.

Jason Mccarthy: Jason McCarthy, Edward Woo, James Molloy, Jenene Thomas Hello and welcome to the AIM ImmunoTech Second Quarter 2024 update conference calling webcast.

Unknown Executive: Jason McCarthy, Edward Woo, James Molloy, Jenene Thomas Hello and welcome to the AIM ImmunoTech Second Quarter 2024 update conference calling webcast. As a brief reminder, all participants are currently in a listen only mode. If anyone requires operator assistance or an event, please press star zero on your telephone keypad. Follow the presentation, there'll 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, follow the end of the event.

Unknown Executive: As a brief reminder, all participants are currently in a listen only mode.

Unknown Executive: If anyone requires operator assistance or an event, please press star zero on your telephone keypad.

Unknown Executive: Follow the presentation, there'll be a question and answer session.

Unknown Executive: Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website, follow the end of the event.

Unknown Executive: At this time of lecture, reminder 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 uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the Federal Security's laws and are based on AIM ImmunoTech's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements.

Unknown Executive: Forward-looking statements on this call are made pursuant to the safe harbor provisions of the Federal Security's laws and are based on AIM ImmunoTech's current expectations and actual results could differ materially.

Unknown Executive: As a result, you should not place undue reliance on any forward-looking statements.

Unknown Executive: Some of the factors that could cause actual results differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports in ImmunoTech files which is carried in 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 view these documents carefully. Additionally, certain information contained in this webcast relates to or is based on a studies, on studies, publication surveys, and other data obtained from third-party sources and the company's own estimates and research.

Unknown Executive: We encourage you to view these documents carefully.

Unknown Executive: Additionally, certain information contained in this webcast relates to or is based on a studies, on studies, publication surveys, and other data obtained from third-party sources and the company's own estimates and research.

Unknown Executive: While the company believes third-party sources to be reliable as of the day of this presentation, it is not independently verified and makes no representation as to the advocacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from third-party sources.

Unknown Executive: Joining us on today's call from the AIM ImmunoTech leadership team are Thomas Equals, Chief Executive Officer, and Christopher McLear, PhD Scientific Officer.

Thomas Equels: Joining us on today's call from the AIM ImmunoTech leadership team are Thomas Equals, Chief Executive Officer, and Christopher McLear, PhD Scientific Officer. I now let's turn the conference call over to Tom Equals, CEO. Please proceed. Thank you, operator, to get started. I'd like to say that I cannot be more proud, not just of our team at AIM, but of our key clinical partners at Top Cancer Research Centers for their hard work and continued focus on execution of clinical trials demonstrating Ampligence Potential.

Thomas Equels: I now let's turn the conference call over to Tom Equals, CEO.

Unknown Executive: Please proceed.

Thomas Equels: Thank you, operator, to get started.

Thomas Equels: I'd like to say that I cannot be more proud, not just of our team at AIM, but of our key clinical partners at Top Cancer Research Centers for their hard work and continued focus on execution of clinical trials demonstrating Ampligence Potential.

Thomas Equels: Over the past quarter we have been working diligently to advance the Amplogen across all of our development programs. Of note, over the past quarter, we continue to generate data that demonstrates the potential of Amplogen in oncology. These new positive data showed that in combination with dendritic cell vaccines, including anti-PD1, PDL1 checkpoint inhibitors, Amplogen slowed tumor growth with improved survival in a preclinical model. This encouraging data was published in the prestigious peer-reviewed journal vaccine.

Thomas Equels: While preclinical, these data do give us confidence as we advance our active, ongoing clinical oncology programs in pancreatic and ovarian cancer.

Thomas Equels: I'd also like to point everyone toward our last quarterly update, Colin May, which because of timing covered many of our accomplishments in the second quarter. Those included updates in both our pancreatic cancer and ovarian cancer work, as well as the GMP manufacturer of approximately 9,000 clinical valves of amplition.

Thomas Equels: Additionally, earlier this year, we made a commitment to all of our stakeholders, the transparency would be at the forefront of what we do.

Thomas Equels: We believe we are holding true to this commitment and continue to be active on the CEO corner program, which we launched earlier this year. Through this platform, which can be found on our website and posted on social media, we strive to provide information and access. And I invite all of you to go to the CEO corner on our website, sign up for the alerts and also submit topics of interest that you would like us to cover.

Thomas Equels: And I invite all of you to go to the CEO corner on our website, sign up for the alerts and also submit topics of interest that you would like us to cover.

Christopher McAleer: Now to go into the details of our recent clinical advancements, I'd like to turn this call over to our science officer, Dr. Chris McAleer.

Christopher McAleer: Now to go into the details of our recent clinical advancements, I'd like to turn this call over to our science officer, Dr. Chris McAleer. Thank you, Tom. I will give a brief overview of the clinical status of our priority development program and I'll start with DoraPank. DoraPank is a phase one, two trial to determine the safety and efficacy of combining ampligen with AstraZeneca's devaluemab in the treatment of metastatic pancreas cancer. We announced recently that the first cohort of the dose escalation had completed the safety evaluation and the medical review committee agreed to move forward with the next dosing level.

Christopher McAleer: Thank you, Tom.

Christopher McAleer: I will give a brief overview of the clinical status of our priority development program and I'll start with DoraPank. DoraPank is a phase one, two trial to determine the safety and efficacy of combining ampligen with AstraZeneca's devaluemab in the treatment of metastatic pancreas cancer. We announced recently that the first cohort of the dose escalation had completed the safety evaluation and the medical review committee agreed to move forward with the next dosing level.

Christopher McAleer: The three patients to be evaluated in the second grouping of the three and three design have since finished the safety evaluation and this dose level was also deemed safe. Additional patients are being enrolled at this highest dose level, which is 1,500 milligrams devaluemab and 400 milligram ampligen. And these are the last three patients of the phase one portion. And together with the other three already receiving this dose will be included as the first patients of the phase two efficacy evaluation.

Christopher McAleer: And these are the last three patients of the phase one portion.

Christopher McAleer: And together with the other three already receiving this dose will be included as the first patients of the phase two efficacy evaluation.

Christopher McAleer: The first patients of the initial 200 milligram dose level are reaching the next efficacy evaluation, which is set for week 24.

Christopher McAleer: The first patients of the initial 200 milligram dose level are reaching the next efficacy evaluation, which is set for week 24. And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12. And the first patient continues to have stable disease at week 24. And while this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression free survival we saw with ampligen alone in the EAP conducted at Erasmus.

Christopher McAleer: And I want to remind everyone that the initial data indicated two stable disease and one minor progression at week 12.

Christopher McAleer: And the first patient continues to have stable disease at week 24.

Christopher McAleer: And while this is preliminary data from three patients at the lowest dose level, these patients already have average stable disease time that is similar to the median progression free survival we saw with ampligen alone in the EAP conducted at Erasmus. And this has us excited. And as of our last update earlier this week, two of those patients still have stable disease. And we are hopeful that we will see responses from these patients even at that lower ampligen dose.

Christopher McAleer: And this has us excited. And as of our last update earlier this week, two of those patients still have stable disease. And we are hopeful that we will see responses from these patients even at that lower ampligen dose. The time to response of immunotherapies is in the weeks to month range, depending on the tumor type. And also, we expect the response to be slower than might be seen in other tumor types based on the fact that pancreatic tumors have a thick, fibrous, desmoplastic nature, which makes immune infiltration more different.

Christopher McAleer: Medical.

Christopher McAleer: Medical. And so that is where we stand with our clinical progress and metastatic pancreas cancer.

Christopher McAleer: And so that is where we stand with our clinical progress and metastatic pancreas cancer.

Christopher McAleer: But in regards to our work in local advanced pancreas cancer, we have received the FDA's written response to our type D meeting package in June. The FDA has agreed in principle with our proposed changes to the inclusion criteria and treatment arms, and we are working on finalizing approval of the protocol changes. While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different US institutions.

Christopher McAleer: While our progress might seem slow from the outside looking in, this is a complex disease with a range of treatment standards across different US institutions. So it is important that the trial be managed so as to maximize the usefulness of the data we receive while keeping trial costs within reason.

Christopher McAleer: So it is important that the trial be managed so as to maximize the usefulness of the data we receive while keeping trial costs within reason. And this is especially important when it comes time to consider future steps in the development of a treatment. When we have full regulatory go ahead to proceed, we believe this new protocol will allow for greater sight and patient recruitment in the U.S.

Christopher McAleer: And this is especially important when it comes time to consider future steps in the development of a treatment.

Christopher McAleer: When we have full regulatory go ahead to proceed, we believe this new protocol will allow for greater sight and patient recruitment in the U.S.

Christopher McAleer: Our last oncology update relates to the advanced recurrent ovarian cancer trial using Amplogen plus Pembrolysmab and Sysplatin in platinum sensitive ovarian cancer. Based on conversations with Dr. Robert Edwards at the University of Pittsburgh, we know that the results thus far are better than he had expected, and patients have seen a clinical benefit rate of greater than 60%. In addition, he was also quite impressed with the immune changes to the tumor microenvironment, and the trial was proceeding so well that he feels there is no need to enroll the total 45 patients as originally planned.

Christopher McAleer: And therefore, the trial is wrapping up enrollment and future steps are being planned, and you should see manuscripts highlighting the data coming from the University of Pittsburgh as early as the end of the year. As great as the initial response data is, I am personally the most interested in seeing the follow-up data with the duration of response. As you know, chemotherapy regimens have been effective in generating response data in these patients, but unfortunately for those who are afflicted, the sad reality is a variant cancer notoriously comes back with a recurrence rate of approximately 80% for stages 3 and 4 patients. We believe the immune modulating properties of this treatment and amplogens potential to modulate the immune milieu of the tumor microenvironment might help in this regard.

Christopher McAleer: As great as the initial response data is, I am personally the most interested in seeing the follow-up data with the duration of response.

Christopher McAleer: As you know, chemotherapy regimens have been effective in generating response data in these patients, but unfortunately for those who are afflicted, the sad reality is a variant cancer notoriously comes back with a recurrence rate of approximately 80% for stages 3 and 4 patients. We believe the immune modulating properties of this treatment and amplogens potential to modulate the immune milieu of the tumor microenvironment might help in this regard.

Christopher McAleer: And we are also eager to see preliminary data in the Phase II study of advanced recurrent ovarian cancer, combining the amplogen containing chemokine modulation therapy with the splatten and a dendritic cell vaccine, which is now open for recruitment.

Christopher McAleer: And lastly, I want to update you on the progress of amplogen for the post-COVID condition of fatigue.

Christopher McAleer: And lastly, I want to update you on the progress of amplogen for the post-COVID condition of fatigue. We have done a thorough analysis of the data and we have identified certain inclusion criteria that can help delineate the high responders.

Christopher McAleer: We have done a thorough analysis of the data and we have identified certain inclusion criteria that can help delineate the high responders.

Christopher McAleer: We are awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September.

Christopher McAleer: We are awaiting the biomarker data necessary to complete our analysis and expect to receive this data in mid-September. We have also been working with patient advocacy groups to better understand the patient journey and solicited their input on the subsequent trial design. While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial.

Christopher McAleer: We have also been working with patient advocacy groups to better understand the patient journey and solicited their input on the subsequent trial design. While we are still awaiting biomarker data, we believe we have a patient population we can target that will be high responders and that will minimize the size of the subsequent trial.

Christopher McAleer: We are drafting a preliminary regulatory package that we aim to submit to the FDA in Q4.

Thomas Equels: And that is a brief overview of our priority clinical pipeline and I'll hand it back to Tom to discuss the company financials.

Christopher McAleer: And that is a brief overview of our priority clinical pipeline and I'll hand it back to Tom to discuss the company financials. Good job. Thank you very much, Chris.

Unknown Executive: Good job.

Thomas Equels: Thank you very much, Chris.

Thomas Equels: Now I'd like to go into the financial picture. For those of you familiar with the micro-cap biotech sector, it's a rough area over the past couple of years. But we are fortunate that we can announce that we have cash position, which we believe sufficient to fund operations through multiple key milestones that are coming up. Our cash equivalents and marketable securities are $10.1 million as of June 30, 2024. Our research and development expenses for the three months and six months ending in June 30, 2024 were 1.1 million and 3.1 million respectively.

Thomas Equels: And that's compared to 3 million and 5 million for the same period of 2023. General and administrative expenses for the three months and six months that ended June 30, 2024 were 2.6 million and 6.4 million respectively, compared to 2.6 million and 4.8 million for the same period of 2023.

Thomas Equels: Now as we reflect on our progress and the data is what tells the story of the progress that we've made over the past couple years.

Thomas Equels: Now as we reflect on our progress and the data is what tells the story of the progress that we've made over the past couple years. You'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for Amplition. And we are not only excited for the future of the company but we believe that Amplition has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors but the patient populations that we hope to serve also.

Thomas Equels: You'll see that there are numerous articles, various peer-reviewed publications that are publishing data that show a bright future for Amplition.

Thomas Equels: And we are not only excited for the future of the company but we believe that Amplition has the potential to unlock tremendous value for all stakeholders. And when I say stakeholders, I'm not just talking about investors but the patient populations that we hope to serve also.

Thomas Equels: And when you look at our company, you may ask, well why Am, why now?

Thomas Equels: And when you look at our company, you may ask, well why Am, why now? The reason is we have encouraging data that drives our programs. We have multiple ongoing clinical studies at top cancer research institutions. And with regard to two of these studies, we are collaborating with big pharma companies. For example, the Advanced Recurrent Ovarian Cancer Study at Pitt. If you look at the clinicaltrial.gov filing with Merck and Erasmus in the Netherlands, our DuraPank Study is in collaboration with AstraZeneca. So we have all the ingredients we believe for a bright future.

Thomas Equels: The reason is we have encouraging data that drives our programs.

Thomas Equels: We have multiple ongoing clinical studies at top cancer research institutions. And with regard to two of these studies, we are collaborating with big pharma companies. For example, the Advanced Recurrent Ovarian Cancer Study at Pitt.

Thomas Equels: If you look at the clinicaltrial.gov filing with Merck and Erasmus in the Netherlands, our DuraPank Study is in collaboration with AstraZeneca.

Thomas Equels: So we have all the ingredients we believe for a bright future.

Thomas Equels: Thank you very much everybody for your interest.

Unknown Executive: Thank you very much everybody for your interest. At this point, I'd like to open up the floor for questions. Operator? Thank you. And now that you're dumping 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 a question from the queue.

Unknown Executive: At this point, I'd like to open up the floor for questions.

Unknown Executive: Operator?

Unknown Executive: Thank you.

Unknown Executive: And now that you're dumping a question and answer session, if you'd like to be placed in the question queue, please press star one on your telephone keypad.

Unknown Executive: A confirmation tone will indicate your line is in the question queue.

Unknown Executive: You may press star two if you'd like to remove a question from the queue.

Unknown Executive: For participants using speaker equipment and maybe necessary to pick up your handset before pressing star one.

Unknown Executive: For participants using speaker equipment and maybe necessary to pick up your handset before pressing star one. Once again, if you'd like to be placed in the question queue at this time, please press star one on your telephone keypad. One moment please while we pull for questions.

Unknown Executive: Once again, if you'd like to be placed in the question queue at this time, please press star one on your telephone keypad.

Unknown Executive: One moment please while we pull for questions.

Unknown Executive: We reshed of our question and intercession, and at this point I would turn the floor back over for any further closing comments.

Thomas Equels: Again, I just want to thank everybody for their interest, and we're working very hard to fulfill AIM's motto, immunology for a better future.

Unknown Executive: Thank you very much.

Unknown Executive: Thank you, that does conclude today's telecompressor webcast and we just connect to AIM at this time and have a wonderful day.

Unknown Executive: We thank you for your participation today.

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