Full Year 2025 IGC Pharma Inc Earnings Call
Yes.
Operator: Ladies and gentlemen, greetings and welcome to the IGC Pharma Fiscal Year End 2025 Shareholder Update Call.
Operator: Ladies and gentlemen, greetings and welcome to the IGC Pharma Fiscal Year-End 2025 Shareholder Update Call. At this time, all participants have been placed on a listen-only mode. If you have any questions or comments during the presentation, you may press star one on your phone to enter the question queue at any time. We will open the floor for your questions and comments following management's remarks. It is now my pleasure to turn the floor over to your host, Rosalyn Christian with IMS Investor Relations.
Ladies and gentlemen, greetings and welcome to the <unk> pharma fiscal year end 2025 shareholder update call.
Operator: At this time, all participants have been placed on a listen-only mode.
At this time, all participants have been placed on a listen only mode.
Operator: If you have any questions or comments during the presentation, you may press star 1 on your phone to enter the question queue at any time, and we will open the floor for your questions and comments following management's remarks.
If you have any questions or comments during the presentation. You May press star one on your phone to enter the question queue at any time and we will open the floor for your questions and comments following management's remarks.
Rosalind Christian: It is now my pleasure to turn the floor over to your host, Rosalind Christian with IMS Investor Relations.
Speaker Change: It is now my pleasure to turn the floor over to your host Roslyn Christian with IMS Investor Relations.
Rosalind Christian: Thank you and I want to welcome everyone to the IGC Pharma Fiscal Year-End 2025 Shareholder Update Call. For those calling in by phone, a slide presentation to accompany today's remarks is available on our website at igcpharma.com.
Thank you.
Rosalyn Christian: Thank you. I want to welcome everyone to the IGC Pharma, Inc. Fiscal Year-End 2025 Shareholder Update Call. For those calling in by phone, a slide presentation to accompany today's remarks is available on our website at igcpharma.com. Before we begin, I'd like to remind everyone that this conference call may contain forward-looking statements based on our current expectations and projections regarding future events, and are subject to change based on various important factors. In light of these risks, uncertainties, and assumptions, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this call. For more details on factors that could affect these expectations, please see our filings with the Securities and Exchange Commission. On the call today with Ram Mukunda, CEO of IGC Pharma, Inc., and Claudia Grimaldi, CFO.
Speaker Change: Welcome everyone to the ITC pharma fiscal year end 2025 shareholder update call.
Today's calling them by saying a slide presentation to accompany today's remarks is available on our website at IGT pharma Dot com.
Rosalind Christian: Before we begin, I'd like to remind everyone that this conference call may contain forward-looking statements based on our current expectations and projections regarding future events, and are subject to change based on various important factors. In light of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this call. For more details and factors that could affect these expectations, please see our filings with the Securities and Exchange Commission.
Speaker Change: Before we begin I'd like to remind everyone that this conference call may contain forward looking statements based on our current expectations and projections regarding future events and are subject to change based on various important factors.
Speaker Change: In light of these risks uncertainties and assumptions you should not place undue reliance on these forward looking statements, which speak only of the date of this call.
Speaker Change: More details on factors that could affect these expectations. Please see our filings with the Securities and Exchange Commission.
Rosalind Christian: On the call today with Ram Akunder, CEO of IGC Pharma, and Claudia Grimaldi, CFO. The team will provide an update on the business, followed by a question and answer session.
Speaker Change: On the call today with Romack under C. O R. G C pharma and Claudia Granola D C S.
Rosalyn Christian: The team will provide an update on the business, followed by a question and answer session. With that, I would like to turn the call over to management. Please go ahead, Ram.
Speaker Change: The team will provide an update on the business followed by a question and answer session with that I would like to turn the call over to management. Please go ahead Rob.
Rosalind Christian: With that, I would like to turn the call over to management.
Ram Akunder: Please go ahead, Ram. Thank you, Roslyn, and thank you all for participating in this conference call. We have about 20 slides that I would like to present as part of our year-end shareholder update. To give you a brief overview, as many of you know, IGC Pharma develops therapies for Alzheimer's disease and other chronic conditions. Our lead asset, IGC-81, is currently in a phase two trial for agitation in Alzheimer's dementia. And we are, and I will present some data that shows that we are also advancing this towards trials as a potential disease-modifying therapy. We have worked this year on an AI platform and integrated AI into our R&D program.
Speaker Change: Thank you Roslyn and thank you all for participating in this conference call. We have about 20 slides that I would like to present as part of our year end shareholder update.
Ram Mukunda: Thank you, Rosalyn, thank you all for participating in this conference call. We have about 20 slides that I would like to present as part of our year-end shareholder update. To give you a brief overview, as many of you know, IGC Pharma develops therapies for Alzheimer's disease and other chronic conditions. Our lead asset, IGC-AD1, is currently in a phase II trial for agitation in Alzheimer's dementia. I will present some data that shows that we are also advancing this towards trials as a potential disease-modifying therapy. We have worked this year on an AI platform and integrated AI into our R&D program, and we've also worked on an early detection system for Alzheimer's that I will go over. During part of our AI exercises, what we discovered was that one of our Alzheimer's candidates is potentially also a GLP-1 based candidate.
Rob: To give you a brief overview as many of you know ITC pharma develop therapies for Alzheimer's disease and other chronic conditions are lead acid. ITC 81 is currently in a phase two trial for agitation in Alzheimer's dementia, and we are and I represent.
Speaker Change: Some data that shows that we are also advancing <unk> towards trials as a potential disease modifying therapy.
Speaker Change: We have worked this year on our AI platform and integrated AI into our into our R&D program and we've also worked on in early detection system for Alzheimer's that I will go over.
Ram Akunder: And we've also worked on an early detection system for Alzheimer's that I will go over. During part of our AI exercises, what we discovered was that one of our Alzheimer's candidates is potentially also a GLP-1-based candidate. It's an agonist at the GLP-1. at GLP-1, which opens up... the market for metabolic disorders.
Speaker Change: During part of our AI exercises, what we discovered was that one of our.
Speaker Change: Our timeless candidates is potentially also a G. L. P. One based candidate it's an agonist at the GSP one.
Ram Mukunda: It's an agonist at GLP-1, which opens up the market for metabolic disorders. The operational highlights for the financial year 2025 include significant progress on the CALMA trial. That's our phase II trial on agitation. We've added several new sites, as I will show you. We've also advanced IGC-AD1 as a disease-modifying therapy. We've worked on our new diagnostic model, which we're calling MINT-AD, and we've also grown our pipeline into the GLP-1 portfolio. To give you an update on the progress on our phase II trial, just to remind everyone, agitation in Alzheimer's dementia impacts about 76% of Alzheimer's patients. There are about 50 million Alzheimer's patients worldwide and about 7 million in the US. Agitation in Alzheimer's is a group of very hard-to-manage behaviors, and these include physical aggression, verbal aggression, wandering, pacing, excessive motor movements, among several other behaviors. Now, these are not just hard to manage.
Jeff: Jeff you want which opens up.
Jeff: The market for metabolic disorders.
Jeff: Okay.
Ram Akunder: The operational highlights for the financial year 2025 include. Significant progress on the CALMA trial, that's our phase two trial on agitation. We've added several new sites, as I will show you. We've also advanced IGC-81 as a disease-modifying therapy. We worked on our new diagnostic model, which we're calling MINT-AD, and we've also grown our pipeline into the GLP-1 portfolio.
Speaker Change: The operational highlights for the financial year 2025 include <unk>.
Speaker Change: Significant progress on the Cosmos trial, that's our phase two trial of agitation.
Speaker Change: We've added several new flyer, new sites as I will show you.
Speaker Change: We've also advanced ITC 81, as a disease modifying therapy.
Speaker Change: We worked on our new diagnostic model, which we're calling meant a D.
Speaker Change: And we've also grown our pipeline into the <unk> portfolio.
Ram Akunder: To give you an update on the progress on our phase two trial. Just to remind everyone, agitation in Alzheimer's dementia impacts about 76% of Alzheimer's patients. There are about 50 million Alzheimer's patients worldwide and about 7 million in the U.S. Agitation in Alzheimer's is a group of very hard-to-manage behaviors, and these include physical aggression, verbal aggression, wandering, pacing, excessive motor movements. among several other behaviors. Now, these are not just hard to manage. The agitation leads to long-term hospitalization, leads to separation of families, higher mortality, higher use of medications, and it has been shown that it accelerates cognitive decline.
Speaker Change: To give you an update on the progress on our phase two trial.
Speaker Change: Just to remind everyone.
Speaker Change: Magic patient in Alzheimer's dementia impacts about 76% of Alzheimer's patients there.
Speaker Change: There are about 50 million Alzheimer's patients worldwide and about $7 million in the U S.
Speaker Change: Agitation in Alzheimer's is a group of very hard to manage behaviors and these include physical aggression verbal aggression wondering pacing excessive motor movements.
Speaker Change: Among several other behaviors.
Speaker Change: Now these are not just hard to manage.
Ram Mukunda: Agitation leads to long-term hospitalization, it leads to separation of families, higher mortality, higher use of medications, and it has been shown that it accelerates cognitive decline. Currently, there is one FDA-approved medication. It is called brexpiprazole. It costs around $17,000 a year, and it takes about six to 10 weeks to work. It comes with a black box warning. It is also an atypical antipsychotic. Our phase II trial currently is about 146 participants. It is a multicenter, double-blind, randomized, placebo-controlled trial. The primary endpoint is to look at agitation or the reduction in agitation compared to placebo at week 6. Separately, we are also looking at agitation at week 2. The inclusion criteria is essentially the patient has to have Alzheimer's, and the patient also has to have clinically significant agitation.
Speaker Change: The agitation leads to long term hospitalization at least a separation of families higher mortality higher use of medications.
Speaker Change: And it has been shown that would accelerate cognitive decline.
Ram Akunder: Currently, there is one FDA-approved medication called Brexprefazol. It costs around $17,000 a year, and it takes about 6 to 10 weeks to work. It comes with a black box warning. It is also an atypical antipsychotic. Our phase two trial currently is about 146 participants. It's a multi-center, double-blind, randomized, placebo-controlled trial. and the primary endpoint is to look at agitation or the reduction in agitation compared to placebo at week six. And separately, we are also looking at agitation at week two. The inclusion criteria is essentially the patient has to have Alzheimer's and the patient also has to have clinically significant agitation.
Speaker Change: Currently there is one FDA approved medication, it's called bricks prepped result, it costs around $17000 a year and it takes about six to 10 weeks to work. It comes with a black box warning. It is also an atypical antipsychotic.
Speaker Change: Our phase II trial currently is about.
Speaker Change: About 146 participants.
Speaker Change: It's a multi center double blind randomized placebo controlled trial.
Speaker Change: And our two the primary endpoint is to look at agitation or the reduction in agitation compared to placebo at week six.
Speaker Change: And separately, we are also looking at agitation at week two.
Speaker Change: The inclusion criteria is essentially the patient has to have Alzheimer's.
Speaker Change: And the patient also has to have clinically significant agitation and we use this is.
Ram Akunder: And we use a scale called the NPI to essentially grade the patient's agitation level and they have to score a four or more in order to participate in the trial. As I said, we currently have about 22 sites in financial year 2024. We added several of the sites in the U.S. as well as in Canada. In 2025, during the financial year, we added several more sites, and subsequent to the financial year, we added more sites. Currently, we have about 22 sites, and part of the reason why the trial initially was a little bit slow is because this particular patient is very difficult to recruit.
Ram Mukunda: We use a scale called the NPI to essentially grade the patient's agitation level, and they have to score a 4 or more in order to participate in the trial. As I said, we currently have about 22 sites. In financial year 2024, we added several of the sites in the US as well as in Canada. In 2025, during the financial year, we added several more sites, subsequent to the financial year, we added more sites. Currently, we have about 22 sites. Part of the reason why the trial initially was a little bit slow is because this particular patient is very difficult to recruit. They're highly agitated, our patients live at home with a caregiver. Essentially, we're targeting, we have to recruit the dyad, the patient, and the caregiver. It's been a difficult process.
Speaker Change: A scale called the NPI to essentially grade the patient agitation level and they have to score of four or more in order to participate in the trial.
Speaker Change: As I said, we currently have about 22 sites in financial year 'twenty 'twenty four we added several of the sites in the U S as well as in Canada.
Speaker Change: In 2025 during the financial year, we added several more sites and subsequent to the financial year. We added more sites. Currently we have about 22 sites and part of the reason why.
Speaker Change: The trial initially was a little bit slow is because this particular patient is very difficult to recruit their highly agitated.
Ram Akunder: They're highly agitated, and our patients live at home with a caregiver, so you're essentially, we are We're targeting and we have to recruit the dyad, the patient and the caregiver. And it's been a difficult process, however, we have. increased our reach considerably by using geotargeting around each of these sites, where we now have Facebook ads targeting patients that live within a 15-minute radius, and then we're going to expand that to about a 30-minute radius, and then to a 45-minute radius, this is now starting to work, and we're starting to bring in a lot more patients to each of these sites.
Speaker Change: Our patients live at home with a caregiver, so you're essentially where.
Speaker Change: We're targeting and we have to recruit the diet the patient and the caregiver.
Speaker Change: And it's been a difficult process. However, we have.
Ram Mukunda: However, we have increased our reach considerably by using geotargeting around each of these sites where we now have Facebook ads targeting patients that live within a 15-minute radius, and then we're going to expand that to about a 30-minute radius and then to a 45-minute radius. This is now starting to work, and we're starting to bring in a lot more patients to each of these sites. I'm very confident that we can accelerate the completion of this trial. We did release interim data on the first 30 patients, and what we found is very encouraging. We found that our medication acts within 2 weeks. If you look at this particular slide, the magenta-colored graph or the line is our active medication compared to our active placebo, which is the blue line.
Speaker Change: Increased our reach considerably by using.
Speaker Change: Geo targeting around each of these sites, where we now have Facebook ads targeting patients that live within a 15 minute radius and then we're going to expand that to about a 30 minute radius and then to a 45 minute radius. This is now starting to work and we're starting to bring in a lot more patients.
Speaker Change: To each of these sites so I'm very confident that we can accelerate the completion of this trial.
Ram Akunder: So I'm very confident that we can accelerate the completion of this. We did. release interim data on the first 30 patients. And what we found is very encouraging. We found that our medication acts within two weeks. So if you look at this. particular slide, the magenta. colored graph or the line is our active medication compared to our active placebo, which is the blue line. As you can see in week two, there's a considerable difference between the placebo group and the active group. And that difference continues. through to week six, which is our end of trial.
Speaker Change: We did.
Speaker Change: Released interim data on the first 30 patients.
Speaker Change: And what we found is very encouraging.
Speaker Change: We found that our medication.
Speaker Change: Within two weeks. So if you look at this.
Speaker Change: Particular slide.
Speaker Change: The magenta color.
Speaker Change: Colored graph or or the line is our active medication compared to our active placebo, which is the blue line.
Speaker Change: As you can see at week two there's a considerable difference between the placebo group and the active group and that difference continues.
Ram Mukunda: As you can see in week 2, there's a considerable difference between the placebo group and the active group, and that difference continues through to week 6, which is our end of trial. When you compare this or when you overlay this, and this is not a direct comparison with the existing drug, but if you overlay this with the published results from the approved drug, what you see is the approved current medication takes about 6 weeks to start to act. At week 2, there's practically no difference between their placebo and their active, which is marked in the black that you see on this particular graph. We have statistically and clinically significant reduction of agitation at the end of trial, which is week 6. We see a very strong indication that our medication works as early as week 2.
Speaker Change: Through two week, six which is our end of trial.
Speaker Change: When you compare this or when you overlay. This and this is not a direct comparison with the existing drugs.
Ram Akunder: When you compare this or when you overlay this, and this is not a direct comparison with the existing drug. But if you overlay this with the published results from the approved drug, what you see is the approved current medication takes about six weeks to start to act. At week two, there's practically no difference between their placebo and their active, which is marked in the black that you see on this particular graph. So we have statistically and clinically significant reduction of agitation at the end of trial, which is week six. And we see a very strong indication that our medication works as early as week two.
Speaker Change: But if you overlay this with the published results from the approved drug what you see as the approved current medication. It takes about six weeks to start to act at week, two there's practically no difference between their placebo and they're active.
Speaker Change: Which is marked in the black that you see on this particular graph so we.
Speaker Change: We have statistically and clinically significant reduction of agitation at the end of trial, which is week six and we see a very strong indication that our medication works as early as week too.
Ram Akunder: So this is a striking differentiator between our medication. and the existing approved.
Ram Mukunda: This is a striking differentiator between our medication and the existing approved medication. To remind our shareholders and the participants, in preclinical research, what we had found is that our medication modifies amyloid as well as tau. These are the two hallmarks of Alzheimer's. These are plaques and tangles. What we discovered is that our medication is a potential disease-modifying drug. When we went to phase I, we also discovered that it reduces neuropsychiatric symptoms. That's why we launched a phase II on agitation, which is one of the neuropsychiatric symptoms. We slowed down launching a trial on IGC-AD1 as a disease-modifying therapy.
Speaker Change: This is a striking differentiator between our medication and the existing approved medication.
Ram Akunder: Now to remind our shareholders and the participants, in pre-clinical research, what we had found is that our medication modifies amyloid as well as tau. These are the two hallmarks of Alzheimer's. These are plaques and tangles. What we discovered is that Our medication is a potential disease-modifying drug. But when we went to phase one, We also discovered that it reduces neuropsychiatric symptoms. And that's why we launched a phase 2 on agitation, which is one of the neuropsychiatric symptoms. And we slowed down launching a trial on IGC-AD1 as a disease-modifying trial. But what we see is from the preclinical and some of the data that we've gotten from phase one, as well as from the interim results in phase two, that this drug is potentially a disease-modifying therapy because it reduces plaques, it reduces...
Speaker Change: Now to remind our shareholders and the participants in preclinical.
Speaker Change: Research what we have found is that our medication modifies amyloid as well as tough. These are the two hallmarks of Alzheimer's plaques and tangles.
Speaker Change: What we discovered is that.
Speaker Change: Our medication is a potential disease modifying drug.
Speaker Change: But when we went to phase one.
Speaker Change: We also discovered that it reduces neuropsychiatric symptoms.
Speaker Change: And that's why we launched a phase two.
Speaker Change: <unk>, which is one of the neuropsychiatry symptoms and we slowed down launching a trial on ICC 81, as a disease modifying therapy.
Speaker Change: But.
Ram Mukunda: What we see is from the preclinical and some of the data that we've gotten from phase I, as well as from the interim results on phase II, that this drug is potentially a disease-modifying therapy because it reduces plaques, it reduces tangles. It also enhances mitochondrial function in an Alzheimer's. We found that in an Alzheimer's mouse model. It improved spatial memory in an Alzheimer's mouse model. It crosses the blood-brain barrier, and it also has long-term neuroprotection properties. We are looking at this drug. We are now preparing this as a disease-modifying. We will be launching a trial on IGC-81 as a disease-modifying therapy.
Speaker Change: What we see is from the preclinical and some of the data that we've gotten from phase one as well as from the interim results in phase two that this drug is potentially disease modifying therapy, because it reduces plaques.
Speaker Change: It reduces.
Ram Akunder: tangles, it also enhances mitochondrial function in an Alzheimer's. We found that in an Alzheimer's mouse mouse. it improved spatial memory in an Alzheimer's mouse. It crosses the blood-brain barrier. And it also supports long-term, it has long-term neuroprotection properties. So we are looking at this drug. We are now preparing this as a disease modifying. We will be launching a trial on IGC-81. as a disease modifying. But looking at our current Just to remind everyone, again, agitation in Alzheimer's, the way we got here was even though the preclinical data pointed to disease modification, our phase one clinical data showed that we had clinical and statistically significant decreases in neuropsychiatric symptoms, including in agitation.
Speaker Change: Tangos It also enhances mitochondrial function.
Speaker Change: And in Alzheimer's, we found that in another time was mouse model.
Speaker Change: It improved spatial memory.
Speaker Change: And as high risk mouse model.
Speaker Change: It crosses the blood brain barrier.
Speaker Change: And it also supports long term it has long term neuro protection properties. So we are looking at this drug we are now preparing this.
Speaker Change: As a disease modifying we will be launching a trial for all AGC 81.
Speaker Change: As a disease modifying therapy.
Speaker Change: But looking at our current.
Ram Mukunda: Looking at our current, just to remind everyone, again, agitation in Alzheimer's, the way we got here was even though the preclinical data pointed to disease modification, our phase I clinical data showed that we had clinical and statistically significant decreases in neuropsychiatric symptoms, including in agitation. We launched our phase II on agitation. This year we did a lot of work on our AI diagnostics platform. Essentially what we're doing is we are downloading and curating and harmonizing a total of about 108 databases from around the world. We're using these databases to train an Alzheimer's model with three aims. One is to identify groups with high risk factors for Alzheimer's. We're looking at groups of risk factors for Alzheimer's. The second thing that this model will do is to predict cognitive decline 2 to 5 years in advance.
Speaker Change: Just to remind everyone again.
Speaker Change: Again agitation in Alzheimer's the way he got here was even though the preclinical data pointed to disease modification. Our phase one clinical data showed that we had clinical and statistically significant decreases in neuropsychiatry symptoms, including agitation.
Ram Akunder: And so we launched our phase two on it.
Speaker Change: And so we launched our phase two all agitation.
Speaker Change: This year, we did a lot of work on our AI diagnostic platform and essentially what we're doing is we are not we are downloading and curating and harmonizing.
Ram Akunder: This year, we did a lot of work on our AI diagnostic platform. And essentially what we're doing is we are downloading and curating and harmonizing a total of about 108 databases from around the world. And we're using these databases to train an Alzheimer's model. with 3A. One is to identify groups. that with high risk factors for Alzheimer's. So we're looking at groups of risk factors for us. The second thing that this model will do is to predict cognitive decline two to five years in advance. The idea behind this model, behind this AI model, is to deploy it as a doctor's tool to help general practitioners diagnose their patients.
Speaker Change: A total of about 108 databases from around the world.
Speaker Change: And we're using this these databases to train and Alzheimer's model.
Speaker Change: With three aims one is to identify groups.
Speaker Change: That with high risk factors for Alzheimer's. So we're looking at groups of risk factors for Alzheimer's.
Speaker Change: The second thing that this model will do is to predict cognitive decline two to five years in advance.
Ram Mukunda: The idea behind this AI model is to deploy it as a doctor's tool to help general practitioners diagnose their patients. What we found is that in Alzheimer's, false negatives are very high. To give you an example, a patient walks into a general practitioner's office, and the caregiver might complain that, oh, this person's forgetting things. It might get attributed to aging or a normal part of aging. In fact, that person may actually have cognitive decline, and that person may actually be coming down with Alzheimer's. This model will allow the doctor to be able to input various factors, various elements, including clinical data, demographic data, and the model will then group those into risk factors and say this particular patient is at a high risk or at a moderate risk or at a mild risk for getting Alzheimer's.
Speaker Change: Idea behind this model behind this AI model is to deploy it has.
Speaker Change: As a doctor's tube to general practitioners diagnose their patients.
Ram Akunder: What we found is that in Alzheimer's, false negatives are very high. So, to give you an example, a patient walks into a general practitioner's office, and the caregiver might complain that, oh, this person's forgetting things, and it might get attributed to aging, or a normal part of aging. But in fact, that person may actually have cognitive decline and that person may actually be coming down with Alzheimer's. This model will allow the doctor to be able to input various factors, various elements including clinical data, demographic data, and the model will then group those into risk factors and say this particular patient is at a high risk or at a moderate risk or a And in turn, it will predict cognitive decline in a time frame of two to five years in advance.
Speaker Change: What we found is that in Alzheimer's false negatives are very high.
Speaker Change: So to give you an example of a patient walks into a general practitioners office.
Speaker Change: Has and and the caregiver might complain that older persons forgetting things and it might get attribute it to.
Speaker Change: AG or a normal part of aging, but in fact that person may actually have.
Speaker Change: Significant decline and that person may actually be coming down with as Alzheimer's. This model will allow the doctor to be able to input various factors various elements, including clinical data demographic.
Speaker Change: Demographic data.
Speaker Change: And the model was then group those into risk factors and said this particular patient is at a high risk or at a moderate risk or minded risk for getting Alzheimer's and in turn it will predict cognitive decline in the timeframe of two to five years in advance.
Ram Mukunda: In turn, it will predict cognitive decline in a time frame of 2 to 5 years in advance. We think this model is very exciting. We've already tested the model, and based on the initial results that we're getting, we're very excited that this model will actually work and be very useful for doctors. We've called this model MINT-AD, and MINT stands for Multimodal Interpretable Transformer for Alzheimer's. We'll be releasing a lot more news about this model throughout this financial year. Just to give you some highlights on our team's achievements. We were recognized by the NIH for innovation. We were selected as one of the top 15 finalists in the NIA, which is the National Institute on Aging PREPARE Challenge for early Alzheimer's detection. We're very proud of that. The beta version of MINT-AD is up and running.
Ram Akunder: We think this model is very exciting. We've already tested the model, and based on the initial results that we're getting, we're very excited that this model will actually work and be very useful for doctors. We've called this model MINT-AD and MINT stands for Multimodal Interpretable Transformer for Alpha. We'll be releasing a lot more news about this model. throughout this finale.
Speaker Change: We think this model is very exciting we've already tested the model and based on the initial results that we're getting we're very excited that this model will actually work and be very useful for doctors.
Speaker Change: We've called this model meant a D and mint stands for multi modal interpretable transformer for Alzheimer's.
Speaker Change: They will be releasing a lot more news about this model.
Speaker Change: Throughout this financial year.
Ram Akunder: Just to give you some highlights on our team's achievements, we were recognized by the NIH for innovation. We were selected as one of the top 15 finalists in the NIA, which is the National Institute of Aging, Prepare Challenge for Early Alzheimer's Detection. We're very proud of that. The beta version of MINT-AD is up and running, and it's able to differentiate, and it's able to look at risk factors and identify risk factors. We also used AI tools to discover that one of our Alzheimer's candidates is also an agonist at GLP-1. Now that potentially opens this drug up for other metabolic disorders.
Speaker Change: Just to give you some highlights on our team's achievements we were recognized by the NIH for innovation. We were selected as one of the top 15 finalists in the end I E which is the.
Speaker Change: National Institute of aging prepare a challenge for early Alzheimer's detection, we're very proud of that the beta version of Mint, a D is up and running and it's able to differentiate.
Ram Mukunda: It's able to differentiate, and it's able to look at risk factors and identify risk factors. We also used AI tools to discover that one of our Alzheimer's candidates is also an agonist at GLP-1. That potentially opens this drug up for other metabolic disorders. We have about five platform drugs. IGC-AD1, which is in a phase II. We have LMP, which targets neuropsychiatric symptoms and AD pathology. We have the TGR platform, which targets amyloid plaque, that essentially is for early to moderate Alzheimer's. We also have IGC-M platform, which targets both plaques and is a GLP-1 agonist. The IGC-C platform targets tau, it also targets GLP-1. These are our other platform drugs that we are currently developing.
Speaker Change: And it's able to look at risk factors and identify risk factors. We also used AI tools to discover that one of our Alzheimer's candidates is also an agonist at G. L. P. One.
Speaker Change: Now that potentially opens this drug up for other metabolic disorders.
Ram Akunder: We have about five platform drugs, IGC81, which is in a phase two. We have LMP, which targets neuropsychiatric symptoms and AD pathology. We have the TGR platform, which targets amyloid plaque, and that essentially is for early to moderate Alzheimer's. We also have IGC-M platform, which targets both lax and it's a GLP-1 agonist. The IGC-C platform targets tau and it also targets GLP-1. So these are our other platform drugs that we are currently developing. As I mentioned, one of our drugs is a GLP-1 and this could potentially help us target a multi-billion dollar global market for things like weight management or type 2 diabetes.
Speaker Change: We have about five platform drugs, AGC 81, which is in a phase two.
Speaker Change: We have L M P, which targets neuropsychiatry symptoms and 80 pathology, we have the TCR platform, which targets amyloid plaque and that essentially is for early to moderate Alzheimer's.
Speaker Change: We also have IDC M platform, which targets both blacks and it's a G. L. P. One agonist.
Speaker Change: C C platform targets Tau and it also targets <unk>. So these are our other platform drugs that we are currently developing.
Speaker Change: As I mentioned, one of our drugs is a G. L. P. One and this could potentially help us target a multibillion dollar global market for things like waste management or type two diabetes.
Ram Mukunda: As I mentioned, one of our drugs is a GLP-1. This could potentially help us target a multi-billion global market for things like weight management or type 2 diabetes. There is considerable synergies between neuroprotection and metabolic regulation via the GLP-1. It's not unusual that these molecules would actually target GLP-1 as well. We have a very diversified pipeline with GLP-1 candidates as well as Alzheimer's candidates that could capitalize on emerging markets and create substantial long-term value for our shareholders. On the financial front, we are very focused on minimizing dilution and maintaining a clean cap table. We've renewed the $12 million line of credit that we have. We are funding our business through selective capital raises. We're very focused on deploying capital efficiently to advance our drugs through clinical trials at a low cost per patient.
Ram Akunder: And there is considerable synergies between neuroprotection and metabolic regulation via the GLP-1, so it's not unusual that these molecules would actually target GLP-1 as well. But we have a very diversified pipeline with GLP-1 candidates as well as Alzheimer's candidates that could capitalize on emerging markets and create substantial long-term value for our shareholders.
Speaker Change: And there is considerable synergies between neuro protection and metabolic regulation Y D. G. L. P. One so it's not unusual that these that these molecules would actually target G. L. P. One as well, but we have.
Speaker Change: A very diversified pipeline with GSP, one candidates as well as Alzheimer's candidates that could capitalize on emerging markets and create substantial long term value for our shareholders.
Ram Akunder: On the financial front, we are very focused on minimizing dilution and maintaining a clean cap table. We've renewed the 12 million dollar line of credit that we have. We are funding our business through selective capital raising. And we're very focused on deploying capital efficiently to advance our drugs through clinical trials. at a low cost per patient. To give you an example, in a phase two trial, typically costs between $100,000 to $150,000 per patient. we're able to do this for about half the We have an in-house CRO or a clinical research team that manages these trials.
Speaker Change: On the financial front, we are very focused on minimizing dilution and maintaining a clean cap table.
Speaker Change: You've renewed the $12 million line of credit that we have.
Speaker Change: We are funding our business through selective capital raises.
Speaker Change: And we're very focused on deploying capital efficiently to advance our drugs through clinical trials.
Speaker Change: At a low cost per patient to give you. An example in our phase II trials typically cost between 100000 to $150000 per patient.
Ram Mukunda: To give you an example, in a phase II trial, typically costs between $100,000 to 150,000 per patient. We're able to do this for about half the cost. We have an in-house CRO, or a clinical research team, that manages these trials, and we're able to keep the cost very low. We have multiple pending clinical and AI milestones that we hope will lead to a reduction of the cost of capital for the company. In addition, the board has aligned management's incentives that include stock options and bonuses with those of the investors. We now have performance-based stock options and bonuses. There are several upcoming milestones that you should be focused on. One of them is to initiate IND-enabling studies for expanding our pipeline.
Speaker Change: We're able to do this for about half the cost.
Speaker Change: We have an in house CR or a clinical.
Speaker Change: Research team that manages these trials.
Ram Akunder: and we're able to keep the cost very low. We have multiple pending clinical and AI milestones that we hope will lead to a reduction of the cost of capital for the country. In addition, the board has aligned management's incentives that include stocks, options, and bonuses with those of the investors, so we now have performance-based stock options and bonuses.
Speaker Change: And we're able to keep the costs very low.
Speaker Change: We have multiple pending clinical and AI milestones that we hope will lead to a reduction of the cost of capital for the company.
Speaker Change: In addition, the board has aligned management incentives that include stock options and bonuses with those at the investors. So we now have performance based stock options and bonuses.
Ram Akunder: There are several upcoming milestones that you should be focused on. One of them is to initiate high-end enabling studies for expanding our pipeline. Second would be to complete the phase two trial. and to expand IGC-AD1 as a disease-modifying treatment with phase 2 trial targeted for late calendar year 2020.
Speaker Change: There are several upcoming milestones that you should be focused on.
Speaker Change: One of them is to initiate IND, enabling studies for expanding our.
Speaker Change: Pipeline second would be to complete the phase two trial.
Ram Mukunda: Second would be to complete the phase II trial and to expand IGC-AD1 as a disease-modifying treatment with phase II trial targeted for late calendar year 2025. With that, I'd like to thank everyone for participating in this conference call. Operator, please open this up for questions.
Speaker Change: And to expand ITC 81, as a disease modifying treatment with phase II trial targeted for late calendar year 2025.
Ram Akunder: With that, I'd like to thank everyone for participating in this conference call.
Speaker Change: With that I'd like to thank everyone for participating in this conference call. Operator. Please open this up for questions.
Operator: Operator, please open this up for questions. Certainly. Everyone at this time will be conducting a question and answer session. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while posing your question, please pick up your handset, if you're listening on speakerphone, to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone.
Speaker Change: Certainly everyone. At this time, we are conducting a question and answer session. If you have any questions or comments. Please press star one on your phone at this time.
Operator: Certainly. Everyone at this time, we'll be conducting a question and answer session. If you have any questions or comments, please press star one on your phone at this time. We do ask, though, while posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star one on your phone. Please hold while we poll for questions. Thank you. Your first question is coming from Gene Carter from Old Mill Capital Partners. Your line is live.
Speaker Change: We do asked a while posing your question. Please pickup your handset if you're listening on speaker phone to provide optimum sound quality.
Speaker Change: Once again, if you have any questions or comments. Please press star one on your phone.
Operator: Please hold Wall-E poll for questions. Thank you.
Speaker Change: Please hold while we poll for questions.
Speaker Change: Thank you. Your first question is coming from gene Carter from Old Mill Capital Partners. Your line is live.
Gene Carter: Your first question is coming from Gene Carter from Old Mill Capital Partners. Your line is live. Hey guys, thanks for taking my questions and congrats on all the progress. Just a couple for me, could you provide us with a bit more insight into the competitive landscape? specifically what other drugs that are available to Alzheimer's patients right now. Gene, thank you for that question. Yes, the current Alzheimer's treatment landscape primarily includes cognitive enhancers like Aricept, Memantine. These help with cognitive symptoms, but they don't alter the course of the disease. Recently approved disease-modifying therapies like licanumab, dananumab for early Alzheimer's, now both of these target amyloid plaques.
Speaker Change: Hey, guys.
Gene Carter: Hey, guys. Thanks for taking my questions, and congrats on all the progress. Just a couple from me. Could you provide us with a bit more insight into the competitive landscape, specifically what other drugs that are available to Alzheimer's patients right now?
Gene Carter: Thanks for taking my questions and congrats on all the progress just a couple for me could you provide us with a bit more insight into the competitive landscape.
Gene Carter: Typically what other drugs that are available to Alzheimer's patients right now.
Jean: Jean Thank you for that question.
Ram Mukunda: Gene, thank you for that question. Yes. The current Alzheimer's treatment landscape primarily includes cognitive enhancers like ARICEPT, memantine. These help with cognitive symptoms, but they don't alter the course of the disease. Recently approved disease-modifying therapies like lecanemab, donanemab for early Alzheimer's. Both of these target amyloid plaque, and these drugs have generated a significant amount of attention. There are challenges, including cost, delivery via infusion, and strict eligibility requirements tied to biomarkers and imaging. On the agitation side, which is where IGC-AD1 is, agitation impacts, as I mentioned, about 76% of Alzheimer's patients. There's one drug, brexpiprazole, and this was approved last year. This is effective in some cases, but it does carry a black box warning. It has a late onset, meaning it takes about 6 weeks to start acting.
Jean: Yes.
Gene Carter: Alright, that's behind this treatment landscape.
Gene Carter: It really includes cognitive enhancers like Aricept.
Gene Carter: The amendment pool.
Gene Carter: These help with cognitive symptoms, but they don't alter the course of the disease.
Gene Carter: Recently approved disease modifying therapies like they kind of lab demand a mab for early Alzheimer's now.
Gene Carter: Both of these target amyloid plaque.
Ram Akunder: and these drugs have generated a significant amount of attention, but there are challenges including cost, delivery via infusion, and strict eligibility requirements tied to biomarkers and imaging. Now, on the agitation side, which is where IGC81 is, agitation impacts, as I mentioned, about 76% of Alzheimer's patients. This one drug, Brexpreprazole, and this was approved last Now, this is effective in some cases, but it does carry a black box warning. It has a late onset, meaning it takes about six weeks to start acting. It's an atypical antipsychotic, and it's often used very cautiously because of concerns around side effects in older populations.
Gene Carter: And these drugs are generally generated a significant amount of attention, but there are challenges, including cost delivery by our infusion.
Gene Carter: And strict eligibility requirements tied to Biomarkers biomarkers and imaging.
Gene Carter: Now on the agitation side, which is where IGT 81 is agitation.
Gene Carter: Impacts as I mentioned about 76% of Alzheimer's patients. This one drug brakes represented.
Gene Carter: And this was approved last year.
Gene Carter: This is effective but in some cases, but it does carry a black box warning. It has the late onset meaning it takes about six weeks to start acting it's an atypical antipsychotic and it's often used very cautiously because of concerns around side effects in the older populations.
Ram Mukunda: It's an atypical antipsychotic, and it's often used very cautiously because of concerns around side effects in older populations. IGC-AD1, our drug, is differentiated in several ways. For one, it's an oral investigational therapy. It's a liquid formulation that individuals would take one dropper full in the evening and one dropper in the morning. That's the dosing that we're currently testing in the phase II. So far all of the data shows that it's well-tolerated. It's potentially multifunctional. That means impacting agitation, but also helping with sleep. Based on our preclinical data, it could also impact core neuropathological features like neuroinflammation, mitochondrial dysfunction. I think IGC-AD1 can be positioned as a complementary or alternative solution to current options, particularly in symptomatic management, where there are very large gaps currently.
Ram Akunder: IGC-81, our drug, is differentiated in several ways. For one, it's an oral investigational therapy. It's a liquid formulation that individuals would take one dropper full in the evening and one dropper in the morning. That's the dosing that we're currently testing in the phase two. So far, all of the data shows that it's well-tolerated. And it's potentially multifunctional, that means impacting agitation, but also helping with sleep. And based on our preclinical data, it could also impact core neuropathological like neuroinflammation, mitochondrial dysfunction. So I think IGC-81 can be positioned as a complementary or alternative solution to current options, particularly in symptomatic management where there are very large gaps.
Speaker Change: I G. C 81, our drug is differentiated in separate ways.
Speaker Change: For one it's an oral investigational therapy, it's a liquid formulation that individuals would take one drop her full in the evening and one dropper in the morning. That's the that's the dosing that we're currently testing in the phase II, it's so far at.
Speaker Change: All of the data shows that it's well tolerated.
Speaker Change: And it's potentially multi functional.
Speaker Change: That means impacting agitation, but also helping with sleep.
Speaker Change: And based on our <unk>.
Speaker Change: Pre clinical data it.
Speaker Change: It could also impact core neuro for pathological features like neuro inflammation by the country of dysfunction. So I think I just see 81 can be positioned as a complementary or alternative solution. The current options, particularly in symptomatic management.
Speaker Change: They're very large gaps currently.
Speaker Change: Okay.
Gene Carter: Got it. That's, that's very helpful. Thank you.
Gene Carter: Got it. That's very helpful. Thank you. You guys have added some trial sites over the past six months, as you mentioned. Do you feel that you have enough sites to complete the current trial, or do you anticipate having to add additional sites?
Speaker Change: Got it that's that's very helpful. Thank you and then you guys.
Ram Akunder: And then, you know, you guys have added some trial sites over the past six months, as you mentioned, do you feel that you have enough sites to complete the current trial or do you anticipate having to add additional sites? So, Gene, currently we have about 22 sites under contract, and these are mostly in the U.S., and we have several in Canada. And we are now currently using a geo-targeting. Strategy around each of the clinical sites. So what we do is go on to Facebook and we use Facebook targeting around right now. It's about a 15 minute or a 20 minute radius around each of the sites.
Speaker Change: Added some trials sites over the past six months as you mentioned.
Speaker Change: Do you feel that you have enough sites to complete.
Speaker Change: The current trial or do you anticipate having to add additional sites.
Gene Carter: So gene currently we have about 22 sites under contract and these are mostly in the U S and we have several in Canada.
Ram Mukunda: Gene, currently we have about 22 sites under contract, and these are mostly in the US, and we have several in Canada. We are now currently using a geotargeting strategy around each of the clinical sites. What we do is go onto Facebook, and we use Facebook targeting around, right now, it's about a 15-minute or a 20-minute radius around each of the sites. This has increased our registrations and enrollment by about 200%. Our aim is to keep expanding this and increasing the radius, say from 15 minutes to maybe 30 minutes to 45 minutes. We're hoping that we can expand our enrollment to about 500%. Based on the current recruitment, current velocity, which we're adding, the existing sites are projected to meet our enrollment targets, and we anticipate maintaining the current site network. We don't plan to add new sites.
Speaker Change: And we are now currently using E G.
Gene Carter: Geo targeting.
Gene Carter: Okay.
Gene Carter: Gratitude around each of the clinical sites. So what we do is go onto Facebook and we use Facebook targeting them around.
Gene Carter: Around there right now there's a it's about a 15 minute.
Gene Carter: A 20 minute radius around each of the sites and this has increased our.
Ram Akunder: And this is increased our. Registrations and enrollment by about 200. So our aim is to keep expanding this and increasing the radius, say from 15 minutes to maybe 30 minutes to 45 minutes. And we're hoping that we can expand our enrollment to about 500%. So based on the current recruitment, current velocity, which we're adding, the existing sites are projected to meet our enrollment target. and we anticipate maintaining the current site network. So we don't plan to add new sites, however, if enrollment slows or there are unforeseen delays, we have contingencies. We've talked to other sites as well in the Northeast and in the Midwest, so we would be able to very quickly add more if they're needed.
Gene Carter: Registrations and enrollment by about 200%. So our aim is to keep expanding this and increasing the radios sit from 15 minutes to maybe 30 minutes to 45 minutes and we're hoping that we can expand our enrollment of about 500%. So based on the current route.
Gene Carter: Men current velocity, which we're adding the existing sites are projected to meet our enrollment.
Speaker Change: Our gets <unk>.
Speaker Change: And we anticipate maintaining the current site network. So we don't plan to add new sites. However is enrollment slows or theyre unforeseen delays, we have contingencies, we've talked to other sites as well in the northeast and in the Midwest. So we would be able to very quickly add.
Ram Mukunda: However, if enrollment slows or there are unforeseen delays, we have contingencies. We've talked to other sites as well in the Northeast and in the Midwest. We would be able to very quickly add more if they're needed.
Speaker Change: More if they're needed.
Gene Carter: Got it. Makes sense. All right. That's very helpful. Congrats on the progress again, and thanks for taking my question. Thank you.
Speaker Change: Got it makes sense alright, that's very helpful. Ah Congrats on the progress again and thanks for taking my questions.
Gene Carter: Got it. Makes sense. All right. That's very helpful. Congrats on the progress again. Thanks for taking my questions.
Speaker Change: Thank you. Your next question is coming from Ed Woo from <unk> capital. Your line is live.
Operator: Thank you. Your next question is coming from Ed Woo from Ascendiant Capital. Your line is live.
Ed Wu: Your next question is coming from Ed Wu from Ascendiant Capital. Your line is live. Yeah, congratulations on all the progress. My question is, you mentioned that you're going to use Facebook to do this geo-targeting. Is that going to increase the cost of the clinical trials to have to, you know, utilize this social media for improvement?
Ed Woo: Yeah. Congratulations on all the progress. My question is you mentioned that youre going to use Facebook to do the Geo targeting is not going to increase the cost of the clinical trials.
Edward Woo: Yeah. Congratulations on all the progress. My question is, you mentioned that you're going to use Facebook to do the geotargeting. Is that going to increase the cost of the clinical trials to have to utilize this social media for recruitment?
Gene Carter: Utilized.
Gene Carter: Yes.
Gene Carter: More.
Gene Carter: Okay.
Ram Akunder: And that's an excellent question. We have done the calculations and we are budgeting about $1,000. for new recruited patients. So, you know, we're almost halfway through. We need another, call it 80. Patience To complete the trial, so 80 times a thousand dollars. That's sort of our. So, it's not going to increase the cost of the trial considerably.
Speaker Change: And that's an excellent question, we have done the calculations and we are budgeting about a thousand dollars.
Ram Mukunda: Edward Woo, that's an excellent question. We have done the calculations, and we are budgeting about $1,000 per new recruited patient. We're almost halfway through. We need another, call it 80 patients to complete the trial. 80 times $1,000. That's sort of our budget. It's not going to increase the cost of the trial considerably. It will increase it marginally.
Gene Carter: Or new recruited patient. So you know we're almost halfway through.
Gene Carter: We need another.
Gene Carter: Call It 80.
Gene Carter: Patients.
Gene Carter: To complete the trial.
Gene Carter: So 80 times a thousand dollars, that's sort of a budget.
Gene Carter: So it's not going to increase the cost of the trial considerably it will add in.
Ram Akunder: It will add, you know, it'll increase the margin. That sounds good.
Gene Carter: It'll increase marginally.
Gene Carter: That sounds good at them.
Edward Woo: That sounds good. Have you given an updated timeline of when we may expect either the next interim data or for the completion of the trial?
Ed Wu: Have you given an updated timeline of where we may expect either the next interim data or for the completion of the trial? Ed, we don't plan to look at interim data, where we are very encouraged by the interim data on the first 30 patients. As you know, we had very good p-values at the end of trial. We had p-value of less than 0.05, which essentially means that the trial is going well. There is a differentiation between the active group and the placebo group. We also saw excellent results, very low p-values for sleep, both at two-week mark as well as at the six-week mark.
Gene Carter: Have you given an updated timeline or what we may expect are there extra interim data or what was the completion of the trial.
Ram Mukunda: Edward, we don't plan to look at interim data where we are very encouraged by the interim data on the first 30 patients. As you know, we had very good P values at the end of trial. We had P value of less than 0.05, which essentially means that the trial is going well. There is a differentiation between the active group and the placebo group. We also saw excellent results, very low P values for sleep, both at 2-week mark as well as at the 6-week mark. We're very encouraged by the interim data that we already saw. We don't plan to do another interim look. If we were to do that, there would be a penalty, and we would have to increase the number of patients. To avoid the penalty, what we're going to do is focus on completing the trial.
Gene Carter: And we don't plan to look at interim data.
Speaker Change: We are very encouraged by the interim data on the first 30 patients as you know we had very good P values at the end of trials, we had P value of less than <unk>, five which essentially means that the trial is going well there is a differentiation between the active group and the placebo group we also.
Gene Carter: The excellent results very low P values for sleep, both at two week, Mark as well as the six week Mark. So we're very encouraged by the interim data that we already saw so we don't plan to do another interim.
Ram Akunder: So we're very encouraged by the interim data that we already saw. So we don't plan to do another interim look. If we were to do that, there would be a penalty, and we would have to increase the number of So to avoid the penalty, what we're going to do is focus on completing the trial. We are very confident at the current rate at which we're going that we're trying to get this trial done this fiscal year and get the results. Great. Well, thank you. And I wish you guys good luck. Thank you. Thanks, Ed.
Gene Carter: Look if we work to do that there would be a penalty and we would have to increase the number of patients. So to avoid the penalty work for them to do is focus on completing the trial. We are very confident at the current rate at which we're going that we're trying to get this trial done this fiscal year and get the results out.
Ram Mukunda: We are very confident at the current rate at which we're going, that we're trying to get this trial done this fiscal year and get the results out.
Gene Carter: Right well, thank you and I wish you guys. Good luck. Thank you.
Edward Woo: Great. Well, thank you, and I wish you guys good luck. Thank you.
Ram Mukunda: Thanks, Ed.
Speaker Change: Thanks, Ed.
James Malloy: Thank you. Your next question is coming from James Malloy from Alliance Global Partners. Your line is live. Hi, Ram. Thanks for taking my question. What's the current expectation for the COMA trial top line? I think with last guidance, I may have missed it, was last guidance in February was suggesting maybe a second half of this year. Any updates on that?
Speaker Change: Thank you. Your next question is coming from James Molloy from Alliance Global Partners. Your line is live.
Operator: Thank you. Your next question is coming from James Molloy from Alliance Global Partners. Your line is live.
James Molloy: So Ron Thanks for taking my question, what's the current expectation for the sarcoma trial topline I think with last guidance.
James Molloy: Hi, Ram. Thanks for taking my question. What's the current expectation for the CALMA trial top line? I think with last guidance, maybe I missed it, last guidance in February was suggesting maybe H2 of this year. Any updates on that? Then for the plaque tangle trial, could you walk us through what that'll look like and sort of size, cost, and time to run that, please? Thank you.
Speaker Change: Maybe I missed it.
Speaker Change: Well Scott It's February was suggesting maybe second half of this year.
Speaker Change: Any updates on that and then.
Ram Akunder: And then for the plaque tangle trial, could you walk us through what that will look like and sort of size, cost, and time to run that, please? Thank you. Thanks, Jim. As far as the current CALMAR trial is concerned, I think we are almost halfway through. We expect to finish the trial this fiscal year, meaning March of next year. So that's sort of our timeline. Internally, we are more aggressive, but I think that's a pretty good indication as to when we think we can finish that trial. The other areas, what we found is IGC-81 has a lot of potential as far as amyloid or tangles or mitochondria are concerned in Alzheimer's.
Speaker Change: For the.
Speaker Change: Plaque tangled trial could you walk us through what that what that will look like and sort of.
Speaker Change: Size cost and and a time to run that play.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Thanks, Jim.
Ram Mukunda: Thanks, James Molloy. As far as the current CALMA trial is concerned, I think we are almost halfway through. We expect to finish the trial this fiscal year, meaning March of 2025. That's sort of our timeline. Internally, we are more aggressive, but I think that's a pretty good indication as to when we think we can finish that trial. The other areas, what we found is IGC-AD1 has a lot of potential in as far as amyloid or tangles or mitochondria are concerned in Alzheimer's, and that's something that would position IGC-AD1 as a disease-modifying therapy. Our aim is to run a phase II trial. We are looking at several different trial designs. There is one thing that we do need to finish before we can launch that particular trial.
Speaker Change: <unk>.
Speaker Change: As far as the current call electrified is concerned I think we're almost halfway through we expect to finish the trial.
Speaker Change: Fiscal year, meaning March of next year.
Speaker Change: So that's sort of a timeline internally we are you know.
Speaker Change: More aggressive, but but I think that.
Speaker Change: That's a that's a pretty good.
Speaker Change: Indication as to when we think we can finish that trial.
Speaker Change: <unk>.
Speaker Change: Other areas would be found is ITC 81 has a lot of potential in.
Speaker Change:
Gene Carter: As far as.
Gene Carter: Amyloid.
Gene Carter: Or tangles or mitochondria are concerned.
Speaker Change: In in Alzheimer's and that's something that would position IGT 81, as a disease modifying therapy.
Ram Akunder: And that's something that would position IGC-81 as a disease-modifying therapy. So our aim is to run a phase two trial. We are looking at several different. trial designs. There is one thing that we do need to finish before we can launch that particular trial. We're talking to a couple of different universities of cleaning up and even applying for grants to do that particular trial, because there is a lot of interest around amyloid therapy. There's a lot of interest around tau. And our particular medication, IGC-81, has shown that can work on tau. It can decrease tau.
Speaker Change: So our aim is to run a phase two trial, we are looking at several different.
Speaker Change: Trial designs. There is one thing that we do need to finish before we can launch that particular trial, we're talking to a couple of different universities of the teaming up and even applying for grants to do that particular trial because there is a lot of interest around amyloid therapy, there's a lot of interest around Tao.
Ram Mukunda: We're talking to a couple of different universities of teaming up and even applying for grants to do that particular trial because there is a lot of interest around amyloid therapy, there's a lot of interest around tau, and our particular medication, IGC81, has shown that it can work on tau, it can decrease tau, it can decrease tangles, and enhance mitochondrial functioning. This is something that's very unique to IGC81. We're very excited about that. The phase II trial would be a trial that's probably around, it would be a pilot study, so it wouldn't be a very large trial. It would be a trial with maybe 50 patients or so. In terms of cost, as you know, we have an internal CRO, and our cost structure is considerably lower than if we were to use one of the larger CROs.
Speaker Change: And our particular medication IGT 81 has shown that it can work on college can decrease how it can decrease tangles and enhance mitochondrion functioning. So this is something that's very unique to IGT 81. So we're very excited about that so the phase II trial would be a.
Ram Akunder: It can decrease tangles and enhance mitochondrial functioning. So this is something that's very unique to IGC-81. So we're very excited about that. So the phase two trial would be a trial that's probably around, it would be a pilot study. So it wouldn't be a very large trial. It would be a trial with maybe 50 patients or so. In terms of cost, as you know, we have an internal CRO. And our cost structure is considerably lower than if we were to use one of the larger CROs. And I think I did say that typical trials cost between $100,000 to $150,000 per patient.
Speaker Change: A trial that's.
Speaker Change: Around.
Speaker Change: It would be a pilot study so it wouldn't be a very large trial it would be a trial with maybe 50 patients or so.
Speaker Change: In terms of cost as you know we have an internal C. R O and our cost structure is considerably lower than if we were to use one of the largest see arrows and I think I do.
Ram Mukunda: I think, I did say that typical trials cost between $100,000 to 150,000 per patient, and we're at half of that. In terms of cost, I think that's something that's not going to cost us millions and millions of dollars. It's something that we can contain the cost and get that trial done. It's a very exciting area for us because it positions the drug as a potentially disease-modifying therapy.
Speaker Change: I'd say that.
Speaker Change: Typically the trials cost between 100 to $150000 per patient and we are at half of that.
Ram Akunder: And we're at half. So, in terms of cost, I think that's something that's not going to cost us millions and millions of dollars. It's something that we can contain the cost and get that trial done. And it's a very exciting area for us, because it positions the drug as a disease-modifying, as a potentially disease-modifying drug.
Speaker Change: So in terms of cost I think that's something that's not going to cost us millions and millions of dollars.
Speaker Change: That we can contain the cost and get that trial done and it's a very exciting area for us because it positions the drug as a disease modifying as a potentially disease modifying therapy.
Ram Akunder: All right, excellent. And one of the key things that hits a lot of Alzheimer's drugs is ARIA. Any thoughts on that? I presume you haven't seen any indications of that yet. Still waiting on the data, of course. But any thoughts on why you won't see that? Yes, so we've thought long and hard about ARIA. They are connected to the monoclonal antibodies that are in the current two therapies, licanumab and donanumab. So, our medication is not a monoclonal antibody. So, we don't expect ARIA. And currently, we haven't seen any. So, this is something that we think can be very safe and a considerable alternative to the two existing therapies.
Speaker Change: All right excellent and one of the you know one of the key things.
James Molloy: All right. Excellent. One of the key things that hits a lot of Alzheimer's drugs is ARIA. Any thoughts on that? I presume you haven't seen any indications of that yet. Still waiting on the data, of course. Any thoughts on why, which is why you won't see that?
Speaker Change: Things that hits, a lot of all suddenly drugs as area.
Speaker Change: Any thoughts on that because we haven't seen any indications of that yet. So we are on the data of course.
Speaker Change: But any thoughts on what.
Speaker Change: We've already done.
Ram Mukunda: Yes. We've thought long and hard about ARIA. They are connected to the monoclonal antibodies that are the current two therapies, lecanemab and donanemab. Our medication is not a monoclonal antibody, so we don't expect ARIAs, and currently we haven't seen any. This is something that we think can be very safe and considerable alternative to the two existing therapies because, as I said, ours would actually target several of the hallmarks of Alzheimer's. It would target the amyloid plaque. In preclinical, we've been able to show that it targets tangles and increases mitochondrial functioning, which is another pathway to try and get to this disease. That's a very exciting area for us.
Speaker Change: Yes, so we've talked long and hard about our yet they are connected to the monoclonal antibodies that are.
Speaker Change: The current two therapies.
Speaker Change: And don't antibody, so our medications not a monoclonal antibody. So we don't expect our yes and currently we haven't seen any.
Speaker Change: So this is something that we think can be very safe.
Speaker Change: And and considerable alternative to the two existing therapies, because as I said ours would actually target.
Ram Akunder: Because as I said, you know, ours would actually target several of the hallmarks of Alzheimer's. It will target the MLI plaque and preclinical we've been able to show that it targets tangles and increases mitochondrial functioning which is another pathway to try and get to this disease. So that's a very exciting area. Yeah, the safety obviously key.
Speaker Change: Several of the hallmarks of Alzheimer's it would target the.
Speaker Change: Amyloid plaque in the clinical we've been able to show that it targets tangles and increases mitochondria functioning, which is another pathway to try and get to this disease. So that's a very exciting area for us.
Speaker Change: Okay. The safety, obviously key Oh, how do you how do you think on positioning versus.
James Molloy: Yeah, the safety is obviously key. How do you think IGC is positioning versus traditional cannabis that gets used a lot in the space? Personal experience of friend's parents who are going through Alzheimer's and taking cannabis, and it's very effective. How does IGC sort of position against something along those lines should the drug pan out?
Ram Akunder: How do you think on positioning versus a traditional cannabis that gets used a lot in the space? A personal experience of friends' parents who are going through Alzheimer's and taking cannabis and it's very effective. How does IGC sort of position against something along those lines? Should the drug pan out? It's a great, great question, Jim. There's a couple of different things to think about. One is that cannabis on its own is not the solution. Our drug is a combination. It includes THC as well as another molecule in a liquid formulation. So it's very different from just smoking weed.
Speaker Change: Traditional cannabis that gets used a lot in this space.
Speaker Change: Personal experience of friends' friends' parents, who are going through all summers and taken cannabis and is very effective how does the.
Speaker Change: How does that sort of position against or something along those lines.
Speaker Change: Should the drug you know pan out.
Ram Mukunda: It's a great question, Jim. There's a couple of different things to think about. One is that cannabis on its own is not the solution. Our drug is a combination. It includes THC as well as another molecule in a liquid formulation. It's very different from just smoking weed. That's one. Second, the replicability and the actual potency is, as you know, it's a medication, so the tolerance levels are very low. The tolerance, when we say the drug has 2.5 milligrams, it has 2.5 milligrams. It doesn't have 5 milligrams, or it doesn't have 1.5 milligrams. That's very important. Replicability is very important. Tolerance levels are very important. It's a medication, so the combination is very important.
Speaker Change: It's a great great question, Jim there's a.
Speaker Change: A couple of different things to think about one is that and it was on its own is not the solution. Our drug is a combination it includes THC as well as <unk> and other molecules in a liquid formulation. So it's very different from just smoking weed.
Ram Akunder: So that's one. Second, the replicability and the actual potency is, as you know, it's a medication. So the tolerance levels are very, very low. And the tolerance, it's in a very, when we say the drug has 2.5 milligrams, it has 2.5 milligrams. It doesn't have five milligrams or it doesn't have one and a half milligrams. So that's very important. Replicability is very important. Tolerance levels are very important. It's a medication. So the combination is very important. So lots of differentiators between a drug that we're producing. And as you said, someone that can just go out and get cannabis and use cannabis.
Speaker Change: That's one second the replica billety and the the actual potency is as you know it's a it's a medication. So the tolerance levels are very very low and the the Torrance it's in a very.
Speaker Change: When we say the drug has 2.5 milligrams. It has two five milligrams.
Speaker Change: Doesn't have five milligrams or it doesn't have one and half milligram. So that's very important replicable entity is very important tolerance levels are very important it's a medication. So the combination is very important.
Ram Mukunda: Lots of differentiators between a drug that we're producing and, as you said, someone that can just go out and get cannabis and use cannabis. The dosing levels are also very important. Smoking cannabis is not something that you would, for example, you wouldn't give your 80-year-old or 85-year-old mom or dad cannabis to smoke because they could fall, and in that aging population, falls is a very big problem. They could have cardiac issues. Lots of issues with just using cannabis. There's a very big difference between a medicine that's produced after a phase I trial, a phase II trial, a phase III trial, versus just going out and buying cannabis.
Speaker Change: That's the differentiator between a drug that we're producing and as you said someone that can just go out and get cannabis and use cannabis.
James Malloy: The dosing levels are also very important. Smoking cannabis. You know, it's not something that you would, for example, give, you know, you wouldn't give your 80 year old or 85 year old mom or dad. Cannabis to smoke because they could fall and in that aging population falls is a very big problem. They could have cardiac issues, lots of issues with just using cannabis. So there's a very big difference between a medicine that is produced after a Phase 1 trial, a Phase 2 trial, a Phase 3 trial, versus just going out and buying cannabis. Absolutely, absolutely.
Speaker Change: The dosing levels are also very important smoking cannabis.
Speaker Change: It's not something that you would for example, give you know you wouldn't give your eight year old.
Speaker Change: 85 year old.
Speaker Change: Mom or dad.
Speaker Change: Cannabis smoke because they could fall and in that aging population falls is a very big problem because of cardiac issues lots of issues with just using kind of it so.
Speaker Change: There is a very big difference between.
Speaker Change: A medicine that's produced.
Speaker Change: After a phase one trial a phase two trial, a phase three trial versus just going out and buying ahead of us.
Speaker Change: Absolutely absolutely. So final question, then mechanistically looking at G&A kind of down in the fourth quarter pretty dramatically.
James Molloy: Absolutely. The final question, mechanistically, looking at G&A, kind of down in Q4 pretty dramatically. Is that sort of the levels we should expect going forward or more around the $1 million a quarter level that it had been sort of throughout fiscal 2025?
Ram Akunder: And so the final question then mechanistically looking at G&A kind of down in the fourth quarter pretty dramatically, is that sort of the levels we should expect going forward or more around the million dollars a quarter level that had been sort of throughout fiscal 25? No, I think the what we've essentially done is, you know, what I've done is to refocus the company or to focus the company entirely on three things. Number one, getting the trial done as quickly as we can. Number two, launching the phase two trial as a disease-modifying therapy. And number three, deploying a beta version of MENT-AD, which is another thing that we're very excited about because There are 400,000,000 people around the world that have preclinical Alzheimer's, meaning that they have amyloid plaque buildup in their brain, but they are not showing any symptoms. So they're at risk.
Speaker Change: That sort of the levels, we should expect going forward or more around a million dollars a quarter.
Speaker Change: But it had been sort of a throat.
Speaker Change: Fiscal 'twenty five.
Speaker Change: No I think the what what we've essentially done as well.
Ram Mukunda: No, I think what we've essentially done is, what I've done is to refocus the company or to focus the company entirely on 3 things. Number 1, getting the trial done as quickly as we can. Number 2, launching the phase II trial as a disease-modifying therapy. Number 3, deploying a beta version of MINT-AD, which is another thing that we're very excited about because there are 400 million people around the world that have pre-clinical Alzheimer's, meaning that they have amyloid plaque buildup in their brain, but they are not showing any symptoms. They are at risk. Currently, you need a PET scan or a recently approved blood biomarker to even detect those. What we're developing is an AI model, a foundation model for Alzheimer's that can, based on clinical data, based on demographic data, based on socioeconomic data, do 2 things.
Speaker Change: What I've done is to refocus the company or to focus the company entirely on three things.
Speaker Change: One getting the trials done as quickly as we can.
Speaker Change: Number two launching.
Speaker Change: <unk> phase two trial as a disease modifying therapy.
Speaker Change: And number three deploying a beta version of meant a D which is another thing that we're very excited about it because.
Speaker Change: There are 400 million people around the world that have preclinical Alzheimer's, meaning that they have amyloid plaque buildup in their brain, but they are not showing any symptoms. So they are at risk currently you need a pet scan or a recently approved blood biomarker to even detect those.
Ram Akunder: Currently, you need a scan or a recently approved by blood biomarker to even detect those. What we're developing is a model, a foundation model for Alzheimer's that can. based on clinical data, based on demographic data, based on. socio-economic data do three things or do two things. One is to cluster the risk factors and say that this individual You know, that walks into a general practitioner's office has is that risk for Alzheimer's and great that risk in terms of mild, moderate or high. And the second thing it would do is to predict and say that in the next two years, cognitive decline based on a couple of different scales is possible.
Speaker Change: What we're developing is a AI model a foundation module for Alzheimer's.
Speaker Change: It can be.
Speaker Change: Based on clinical data based on demographic data based on.
Speaker Change: So she economic data.
Speaker Change: Three things I'll do two things one.
Ram Mukunda: One is to cluster the risk factors and say that this individual that walks into a general practitioner's office is at risk for Alzheimer's, and to grade that risk in terms of mild, moderate, or high. The second thing it would do is to predict and say that in the next 2 years, cognitive decline based on a couple of different scales is possible, and this is sort of the projection going out 2 years. That helps the doctor to intervene. We're very excited with that as well, and that's something that we're very focused on developing. It can be a tool for general practitioners in America, in rural areas where neurologists might not be available or specialized help might not be available, and PET scans might not be available.
Speaker Change: Clustered in the risk factors and say that this individual.
Speaker Change: You know that walks into a general practitioners office.
Speaker Change: Has he is at risk for Alzheimer's and great that risk in terms of mild moderate or high and.
Speaker Change: And the second thing it will do is to predict and say that in the next two years cognitive decline based on a couple of different scales. It's possible and this is sort of the projection going out two years that helps the doctor to intervene.
Ram Akunder: And this is sort of the projection going out two years that helps the doctor to intervene. And we're very excited with that as well. And that's something that we're very focused on developing. It can be a tool for general practitioners in America and rural areas where neurologists might not be available, or specialized help might not be available, and scans might not be available. So that's something that we could deploy on the web and doctors can actually use it. to diagnose and as an aid, as a doctor's aid. So we've essentially refocused, we're focusing on these three things.
Speaker Change: And we're very excited with.
Speaker Change: That as well and that's something that we're very focused on developing it can be a tool for general practitioners in America in rural areas, where neurologists might not be available or specialized.
Speaker Change: You know help might not be available and Afghans might not be available. So that's something that we could deploy it on the web and doctors can actually use it.
Ram Mukunda: That's something that we could deploy on the web, and doctors can actually use it to diagnose and as a doctor's aid. We're focusing on these three things, and I think that's why the G&A is down, and the G&A has been cut to refocus the company into completing the phase II trial, launching the second phase II trial, and getting MINT-AD to beta testing.
Speaker Change: To diagnose and as I sat and age is a doctor's aid.
Speaker Change: So we had essentially focused we're focusing on these three things and I think you know that's why the G&A is down in the G&A has been cut to refocus the company into completing the phase two trials launching the second phase II trial and getting.
Ram Akunder: And I think, you know, that's why the GNA is down and the GNA has been cut to refocus the company into completing the phase two trial, launching the second phase two trial and getting MINT-AD to beta test.
Speaker Change: The beta testing.
Speaker Change: Okay.
James Malloy: Great. Thank you for taking the question.
Speaker Change: Great. Thanks for taking the questions.
James Molloy: Great. Thank you for taking the questions.
Operator: Thank you, that concludes our Q&A session.
Operator: Thank you. That concludes our Q&A session. I'll now hand the conference back to Ram Mukunda for closing remarks. Please go ahead.
Ron: Thank you that concludes our Q&A session I will now hand, the conference back to Ron <unk> for closing remarks. Please go ahead.
Ram Akunder: I will now hand the conference back to Ram Mukunda for closing remarks. Please go ahead. Thank you. I want to thank everyone for joining our call and in closing I want to say that we are you know committed to address addressing one of the most devastating diseases that that we all face. So and for investors we believe that IGC is at a very exciting juncture with key milestones for the current financial year where as I said we're hyper focused on getting the phase two trial done which and positive results from that can potentially move our valuations considerably.
Speaker Change: Thank you I wanted to thank everyone for joining our call and in closing I want to say that we are committed.
Ram Mukunda: Thank you. I want to thank everyone for joining our call. In closing, I want to say that we are committed to addressing one of the most devastating diseases that we all face. For investors, we believe that IGC is at a very exciting juncture with key milestones for the current financial year, where, as I said, we're hyper-focused on getting the phase II trial done, and positive results from that can potentially move our valuations considerably. We want to launch IGC-AD1 as a disease-modifying therapy, acceptance by the FDA of that trial would also be something that would move our valuations out of the symptoms area to actual disease modification, which command considerably higher valuations. We think that MINT-AD on its own is something that's worth an incredible amount and can also move our valuation.
Speaker Change: Committed to address addressing one of the most devastating diseases that are that we all face. So I hadn't for investors. We believe that <unk> is at a very exciting juncture with key milestones for the current financial year, where as I said, we're hyper focused on getting the phase II trials done which.
Speaker Change: And positive results from that can potentially move our valuations considerably.
Ram Akunder: We want to launch. IGC-81 as a disease-modifying therapy and acceptance by the FDA of that trial would also be something that would move our valuations out of the symptoms area to actual disease modification, which command considerably higher valuations. And we think that MINT-AD on its own is something that's worth, you know, an incredible amount and can also move our valuations. So this is a very exciting time for our investors. We want to thank all of you for being with us. And, you know, as we've said before, we're building a future. We're not just building therapies.
Speaker Change: We wanted to launch.
Speaker Change: You see 81, as a disease modifying therapy and acceptance by the FDA of that trial would also be something that would move our valuations out of the symptoms area to accurate disease modification, which command considerably higher valuations and we think that meant <unk> on its own.
Speaker Change: Is something that's worth an incredible amount.
Speaker Change: And can also move our valuation. So this is a very exciting time for our investors. We want a tank all of you for being with us and as we've said before.
Ram Mukunda: This is a very exciting time for our investors. We want to thank all of you for being with us. As we've said before, we're building a future. We're not just developing therapies, but we're building a future where Alzheimer's is no longer an insurmountable challenge. Thank you, everyone.
Speaker Change: We're building a future.
Speaker Change: We're not just building therapies, whereas we're not just developing therapies, but we're building a future with Alzheimer's is no longer an unsurmountable challenge.
Operator: We're not just developing therapies, but we're building a future where Alzheimer's is no longer an insurmountable challenge. Thank you everyone. Thank you.
Speaker Change: Everyone.
Operator: Thank you. Everyone, this concludes today's event. You may disconnect at this time, and have a wonderful day. Thank you for your participation.
Speaker Change: Thank you everyone. This concludes today's event you may disconnect at this time and have a wonderful day. Thank.
Operator: Everyone, this concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
Speaker Change: You for your participation.