Hello, Ed. Good afternoon, everyone. I'm Rosalyn from IMS Investor Relations. Welcome to our Fireside Chat today. We're really pleased to have with us today Ram Mukunda, who is the Chairman and Chief Executive Officer of IGC Pharma. In addition, we've got Ed Woo, who is senior research analyst at Ascendiant Capital Markets. Ram and Ed, thank you both so much for joining today. I will step back and let you enjoy the discussion. Thank you.
Yeah, I'd like to thank, Rosalyn and IMS for helping us organize this Fireside Chat today, and I have to thank everybody to be here. I'm Edward Woo. I'm a senior analyst here at Ascendiant Capital Markets. We're a broker-dealer, investment bank. We've been covering IGC for several years now, and definitely very excited about this story. So, I'd like to introduce, Ram Mukunda, he's the CEO of IGC. He's obviously, you know, very excited to, to share with you all the updates and information on the, you know, what they are working on. So Ram, just welcome very much for, attending, this Fireside Chat.
Rosalyn, thank you for that introduction, and Ed, thank you for hosting this.
Great. You know, I'd like to just start off a little bit, Ram, with just a quick introduction about your, your background, how long you've been with the company, and kind of, you know, your just immediate, you know, vision for, you know, over the next year or so.
Sure, Ed. My background is that I'm an engineer by training. I have degrees in mathematics as well as in engineering, biomedical engineering, and I ran a public company that I took public in... I ran a company that I took public, my first company called Startec, and then this is the second one. We're very excited to be in this field where we're working on both AI and and actually lead assets in Alzheimer's in general. So we've got drugs that we are that are in preclinical as well as in more advanced stages in Alzheimer's, and we've got a very solid AI program that's addressing the Alzheimer's industry. So we're essentially a clinical stage biotechnology company where we leverage AI.
That sounds good, Ram. Can you tell just a little bit about the drugs you have in the platform? And then maybe after you talk about the drugs that you have in development, talk about how AI is being able to leverage, you know, what you're, the work that you're doing.
Sure. IGC Pharma is a clinical stage biotechnology company. We, essentially, have several assets that are both in Alzheimer's disease as well as in metabolic disorders. Our lead asset is IGC-AD1, and it's a cannabinoid-based therapy that is currently being evaluated in a phase II clinical trial. The trial is called CALMA, and it's for agitation that's associated with Alzheimer's dementia. Alzheimer's affects about 50 million people around the world, and in the U.S. and in North America and Europe, there are about 15 million people with Alzheimer's, and about 76% of them actually have agitation, which is a very difficult to manage symptom, and there's only one drug that's been approved, and it's an antipsychotic. We are currently about 70% of the way through this trial. We have another 30% to go.
We're well on track to, you know, finish the trial by the middle of this year. We have several other assets as well.
Yeah.
We have TGR-63, which is focused on amyloid plaque, and we also have early-stage programs-
Yeah
... for tau neurodegeneration and metabolic dysfunction. In addition, I want to talk about this a little bit, you know, as well, but we can do it later. We have a fairly robust portfolio of patent-protected CBD medications, and there's a lot of talk now about CBD and CBD's use in seniors, and we're well into that space with patent-protected medications in pain, in stuttering, eating disorders, among others. You asked about AI. We're building an AI platform to stratify risk in Alzheimer's, without using things like PET scans, which are very expensive. This is something that could be deployed as an aid or as a tool that practitioners, especially general practitioners, can use to help them detect whether a person, at what risk level a person is for getting Alzheimer's and dementia.
So what it does is, here's sort of the vision for it. You walk in to, you know, it could be a general practitioner, it could be a nurse practitioner, even a community center in rural centers, where you input a lot of information about yourself, things like demographics, you know, your level of education, whether you have other ailments like diabetes or, high blood pressure, or other cardiovascular diseases. And what it does is it stratifies the individual as low, medium, high risk for dementia.
Yes.
It also plots what the cognitive decline would look like over the next several years. Now, armed with that, there are non-pharmacological interventions that can also be modeled using this, using our AI, and that shows how the individual's cognitive decline can be slowed down. And these interventions-
Yeah
... could be changes in diet, exercise, social functioning, or even games that an individual can play, to essentially be mentally active. So that is the vision for that, for MINT-AD and we call it MINT-AD because it's a multi-modal, meaning it takes many different types of input. Multi-modal interpretable because it shows, using various technologies, exactly how it got to the analysis or the conclusion that an individual is at medium risk or at high risk. You know, how did it get there? It's an interpretable, and then the T stands for transformer because we use the latest transformer technology.
Yes.
So it's called MINT-AD, and we've done a lot of work on this, and it's something that we're working very hard on. Getting this done, I think it's going to be a sea change, especially with areas where there's no PET scans. This could be a very effective tool.
That sounds very exciting. Obviously, AI is the buzzword for pretty much the last year and a half in terms of technology. So how advanced and how soon can this, you know, product be introduced and be useful? Is this something that's, you know, gonna be a very long time away, or is this something that you guys can apply very soon?
It's something that we're gonna put into beta testing very soon, like months.
Um, great.
You know, it's being trained on datasets, longitudinal datasets from around the world. We've downloaded... You know, we've probably downloaded, like, 100 datasets from around the world: U.S. datasets, Canadian datasets, datasets in Europe, Asia, and that's what the model is being trained on. So that... And we're using datasets from around the world so that we can reduce bias, we can reduce, you know, the various things that AI, AI models typically end up doing. But it's something that we are very excited about. It's something that we... You know, it's ready. We've putting the final touches on it, and we're going to put it for beta testing. We've also picked out a few centers where we could do this, and we're also applied for-
That sounds very exciting. Will you be introducing this only for the U.S. market, or is this something that could be utilized globally?
The idea is that we would deploy it, of course, globally, but initially it's going to be in... We're going to beta test it in the U.S.
Great. And I remember in the past, you know, your company has had a lot of international connections to be able to take advantage of, you know, lower-cost systems. Is that also the case with this AI model?
Absolutely, Ed. You know, we have connections in India, in Colombia, South America, very strong connections in Puerto Rico, all over the U.S., in Canada. So we're running a trial, the CALMA Trial, in about 23 different trial sites. So we have these connections, so we're going to pick some of these in rural settings and deploy this. We're also looking for partnerships with community centers and community organizations where this can be done.
Well, that's very exciting. So you said maybe, you know, in a couple of months, so maybe by middle of this summer it will be in beta testing.
That's our goal.
That sounds good. So switching back to the CALMA Trial, you also mentioned that you recently announced that you have 70% patient enrollment, and you just said that you expect by the middle of this year to be finished with the trial. Is that correct?
Yeah. So we are, you know, we recently announced that the trial is 70% enrolled, and we are progressing towards getting, you know, 100% enrollment by the middle of this year. To do this, what we've done is we've added new sites. Recently, we've added sites in Colombia, in South America. We've added sites in the U.S.
Yeah.
We're in Canada with the trial. So we're expanding the number of sites, and we've got a very robust enrollment-
Yes
... sort of program where we have educational videos, we have, you know, just to back up a little bit and explain, agitation in Alzheimer's, which is what the trial is about, it affects about 76% of Alzheimer's patients. But agitation is especially difficult because it's not something that's easily recognized by, you know, even the centers where individuals are treated, even a lot of the PIs sort of don't quite get what agitation is. To give you an example, most people think of agitation as physical aggression. You know, someone's physically aggressive, okay, they're agitated. But yelling, screaming, pacing, you know, uncontrolled motor movements, opening and closing drawers, these are all behaviors that make up the symptom called agitation.
And so what we have to do is we have to actually go in and educate people on what agitation is, how to recognize it, and then get them to sign up for the trial. So in order to do this, we have, you know, videos that we've made for education of agitation behaviors. We advertise using these videos on Facebook, and individuals then sign up. What we do is, we've got 23 sites. We geofence around those sites, so sort of say, 45-minute driving radius around a particular site, and then we'll play these videos. And individuals sign up, they fill out a form, they come to us. We have people that call them and explain what the procedure is, what the trial is about, what's expected of them, and then they are then referred to the site for enrollment.
So this is what we're doing, and this is gaining a lot of momentum. In addition, as I said, we're adding sites, we're recruiting patients, so we're very, very enthusiastic, and we're, you know, pushing very hard to get this trial done by the middle of this year.
Once the trial is completed, when will you be able to report top-line data?
Soon after, there's usually a database lock. Once we lock the data and close out the sites, we send the data to an external agency for actually doing the analysis. So it's a third-party statistical company that looks at the data and then produces the statistical report. So I, you know, we're sort of thinking not more than a month or two.
Wow! So maybe by late summer, maybe by-
Yes
... August, September, you'll be able to report on this study. And just to let everybody know, how long has this study been going? And I know you got some positive interim data - several positive interim data. So, you know, hopefully that continues. So how long has it been going, and what kind of data and feedback have you got so far?
Ed, we did an interim analysis on the first 30 patients, and we're not going to unblind to do more interim analysis because that just creates bias. The FDA doesn't like it. We then have to end up expanding the trial beyond the number that we originally said we were going to do, and it just ends up delaying everything. The data remains unblinded. We're blinded, the site is blinded, pretty much everyone in the company is blinded except for one person that's responsible for the unblinding. It's run with a lot of regulatory rigor. The trial, we will not announce more interim results until we close out the trial. Our objective really is to push as hard as we can to get this trial done, and that's what we're focused on.
That sounds good. And obviously, you know, you mentioned, you know, that, you know, you're working on Alzheimer's. That's a big focus of, you know, the drug as well as the company. Can you talk about just the market opportunity for Alzheimer's? Alzheimer's obviously a very debilitating, you know, disease. It predominantly hits older Americans, so it's gonna affect all of us as we age. But the big thing is there's no treatment for it right now. There's no good treatment and, you know, obviously, you know, can you talk about the, you know, the opportunity and what happens if you do... are able to get something that actually works in this space, what, you know, the type of opportunities you have?
So the Alzheimer's space is massive. 50 million people around the world that have Alzheimer's. There's 400 million or so people that are sort of clinical. They have amyloid in their brain, they have plaque in their brains, but and they're at risk for getting Alzheimer's, but they don't have the symptoms yet. So it's a very large market. About 76% of the 50 million have agitation. In the US and in Europe and North America, there's about 15 million. Now, 76% of that is about 11 million people with Alzheimer's. We get a drug for agitation in Alzheimer's, it's a blockbuster drug because just 1%, just 1%, is $1 billion of revenue.
So that's something that, you know, it's a very large indication, it's a very large market, and we're well-positioned to get something out and into this space. Now, our medication differentiates from other medications in a couple of different ways. One, it's faster acting... and we've got data from the interim that shows that as early as 2 weeks, there's a dramatic decrease in agitation. Now, we're also looking at other data points before 2 weeks, so it's possible that the drug acts within 2 or 3 days. That's number one. Number two is that it also seems to impact sleep disturbance. So individuals with Alzheimer's have a lot of sleep disturbance. Our drug can reduce sleep disturbance, as well as reducing agitation. So that's the second sort of data point. The third is that all of our preclinical data shows that our medication is a disease-modifying drug.
So that's something that we're excited about, and that's something that we will put into a trial, you know, later this year. So if you look at the totality of what this drug can do, it's a very exciting drug, 'cause it can reduce agitation, a symptom that affects 76% of people. It's a devastating symptom. It can reduce sleep disturbance, something that impacts a large majority of Alzheimer's patients. And third, it can be potentially disease modifying. So that's another area that we're going to investigate. So once we finish this, there's a lot of different avenues that open up for us. After we finish the trial and we get the safety data, and we get all of the efficacy data, it opens many different pathways, including, of course, agitation, but it opens up all these other pathways as well.
Then beyond Alzheimer's, there's lots of other dementias that we could also target.
I think you mentioned... You know, you're correct. If you have a drug that's able to work in this space, it's gonna be a blockbuster because, again, there is no good treatment for Alzheimer's right in this current state. Is that correct?
That is correct. I mean, there is no good treatment. There's no cure for Alzheimer's. There are drugs that slow it down. The recently announced drugs, donanemab and others, that slow down the progression, those are very exciting drugs that have come out. So it's a very exciting time in the industry.
That sounds good. And, you know, you talk about other, you know, being able to use, you know, these molecules into other different areas. And your product is cannabinoid-based. So can you talk about how that is able to open up other, you know, potential therapeutics, other diseases, other conditions?
Well, yes. Once we, if you look at IGC-AD1 is a cannabinoid-based formulation. It's a liquid formulation. It's administered in this current trial twice a day. So it comes in a bottle, and essentially, the caregiver can give it to the patient at night and then in the morning. So that's the medication. And once we finish this phase II trial, there are many different things that we could do with this. One, we could, you know, potentially enter into a partnership or even sell it. Lots of companies, examples, I'm sure you know this, that have sold a particular drug after a phase II. So we would very clearly look for those kinds of partnerships or we would look for an exit for that indication. That's something that we would look for.
And then, you know, these drugs after phase II go for anywhere from... I mean, we have examples of, you know, $750 million- $3-4 billion. So depending on who's interested and what the potential is, there's a very large opportunity for an exit after phase II. That's one. Second is, we could also start looking at sleep in Alzheimer's. We could look at cognition, which is the holy grail, right? If you can get something that modifies the disease or slows down the decrease in cognition as the disease progresses, that's a home run. That's a massive home run. So, and that's of considerable value. So those are all the different things that it opens up. And it's interesting that it's THC-based. It's a very low dose of THC, so...
With everything going on in the regulatory environment, we're in a very interesting inflection point.
That sounds good. You mentioned, you know, disease modifying. I think, you know, something that you've introduced, last year, and you talked about, you know, pursuing this avenue. Can you talk about the status of it? And you mentioned that, you know, you guys are gonna, you know, potentially take it into the clinics, later this year.
Well, what we want to do is... There's a couple of things that we have to do. We have to look at the, the safety from a chronic use perspective. So, a trial for disease modification is a trial that would go on for a year or two. Agitation trial that we're doing is a six-week trial because the medication can reduce agitation very quickly, so that's a six-week trial. A cognition trial could be a year... where we look at data points between baseline, three months, six months, nine months, 12 months to see what it does. So that's a different kind of a trial, and that's a trial that we would like to initiate.
In order to do that, we have to finish a tox study, which we're in the middle of finishing, and we're hoping that the tox study gets done by, let's say, July or so, July, August. Once that's done, we would then approach the FDA for that longer cognition study.
That sounds great. We're nearing the end of our fireside chat, so I just want to kind of wrap it up and kind of maybe ask you, you know, obviously, you mentioned, you know, the next couple of months you should be finishing your CALMA trial. You'll be, you know, potentially in beta testing with your AI product. What else should we look for, you know, particularly, you know, in the later half of 2026?
So I think the current regulatory environment, and I think it's worth in the next couple of minutes just talking about the current regulatory environment. This is a very exciting place. It's a very exciting time for us because the administration's regulatory momentum, you know, sort of directionally favors IGC considerably, and we think about it in terms of three tailwinds. One of them is the first—the first one is the Mitch McConnell 2026 hemp definition, the amendment to the 2018 bill. Now, from our perspective, this amendment does two things. One, it effectively tightens access to THC from hemp-derived sources coming into the mainstream. That's good for us because it helps us create more of a moat around our medication and around our IP. That's very important.
And then the second is that this amendment draws a bright line between unregulated consumer cannabinoid products and pharmaceutical-grade development, and that's the lane that we are in, and that is what we are doing. The second tailwind that's significant is this, all this talk about the administration, where they're considering CBD for seniors and Medicare reimbursement. Now, given the FDA stance on CBD, this again favors IGC. We have patents for the use of CBD, and this is sort of, you know, we haven't talked about this much, but this is a very, very important inflection point in terms of the regulatory environment, and that's why I'm going to bring it up. We have patents for CBD in pain, in pain management, and as you know, the pain therapeutics drug market is between $30 billion and $35 billion just in the U.S.
It's a massive market. And we have patents for the use of CBD and THC in stuttering. That impact, that affects about 3 million people in the U.S., and about 1% of children have persistent long-term stuttering. And as you know, CBD is non-intoxicating. It's not like THC. In addition, we have patents for seizures in cats and dogs, CBD again, and about between 800,000 and 1.2 million cats and dogs suffer from seizures. It's a very large number. And then this whole third sort of tailwind where with the rescheduling of cannabis, and that reduces Schedule I barriers for us. It reduces the stigma. It also makes banking more comfortable. So we're in a very exciting place, and, you know, we're...
I, and frankly, I think with the cannabinoid program, especially with THC, that we are developing with clinical evidence, quality manufacturing, and with the regulatory discipline, sort of helps validate, I think, the entire industry. And that's the standard that we are setting, and that is where we are creating long-term value for our investors.
Well, it's definitely very exciting times. Again, you know, your focus on, obviously, the cannabinoids, the, you know, AI model that you're working on, and obviously, nearing completion of the CALMA trial are three very major catalysts for you guys. And, you know, again, I, you know, thank you. You know, I really appreciate it. We'll wrap up this call. Ram, thank you very much for your time. I'd like to thank everybody who joined us for this. It's definitely gonna be a very exciting year for IGC, and I look forward to following you guys. And, if any of these investors have questions out there, feel free to reach out to me. Feel free to reach out to the company as well. I'm definitely looking forward to staying in touch and keeping updated on all the stuff you guys do.
So, thank you very much for everybody, and hope you guys have a good day.
Thank you.
Thank you.
Bye-bye.
Thank you, Ram. Bye.