IGC Pharma Mid-Year Fiscal 2026 Earnings Call - Accelerating Phase Two Trial with Promising Early Agitation Data

Conference Operator: Ladies and gentlemen, greetings, and welcome to the IGC Pharma mid-year fiscal 2026 shareholder update call. At this time, all participants are in a listen-only mode. Please note this conference is being recorded. Following management’s remarks, the call line will be opened for questions. It is now my pleasure to introduce your host, Rosalind Christian, with IMS Investor Relations.

Rosalind Christian, IMS Investor Relations, IGC Pharma: Thank you, and I want to welcome everyone to the IGC Pharma mid-year fiscal 2026 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 certain 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, we have Ram Mukunda, CEO of IGC Pharma, and Claudia Grimaldi, CFO.

The team will provide an update on the business, followed by a question-and-answer session. I would like to turn the call over to management. Please go ahead, Ram.

Ram Mukunda, CEO, IGC Pharma: Thank you, everyone, for joining us on our six-month update. As all of you know, IGC has five platform drugs: IGC 81, TGR 63, IGC LMP, M3, and 1C. Each of these is slightly different. As most of you have been following us, as you know, IGC 81 is the most advanced one. It is in a phase two trial, and we’ve announced that we’ve completed over 50% of the trial. We are accelerating this trial, and we’re very, very, very enthusiastic that we will be able to finish this trial in the first, certainly in the first half of next year. This particular drug, as we’ll show you, is also a disease-modifying therapy. The second major thrust that we have is MINT-AD, an AI foundation model for Alzheimer’s that targets early detection and predicts cognitive decline.

One of our candidates, one of our Alzheimer’s candidates, is also a GLP-1-based candidate. We are going to talk about that as well. Before we get into what we are working on, let me just remind all of you of what problem we are solving. Over 55 million people worldwide are living with Alzheimer’s, and over 400 million people are prodromal, or they have Alzheimer’s pathology in the brain, but they do not have any of the symptoms yet. They are all at risk for getting Alzheimer’s. Of the 55 million that have been diagnosed with Alzheimer’s, about 76% have or experience agitation. Current treatments for agitation, there is only one that has been approved by the FDA, comes with a black box warning and takes about 6-10 weeks to start acting.

There is an unmet need, and this unmet need is to come up with a formulation that’s well tolerated and addresses certainly agitation. In our case, as we’ll show you, it also has the potential for addressing the disease itself. We have a multi-asset pipeline, and IGC 81, as you know, is the most near-term opportunity, which we believe will drive shareholder value. We’re hoping that when the results come out, and we’re hoping that the results are good, we have de-risked this by doing two things. We looked at agitation in our phase one trial, and we found that it actually helped the patients. In our phase two, we also have interim results. We’ve done what we can to de-risk it. This TGR 63 we have, which is a novel small molecule, targets amyloid and also tau pathology.

We’re going to talk about MINT-AD, our AI platform. Together, these programs form a precision medicine approach to developing safer and effective treatments for Alzheimer’s. In 2026, I just want to give you some of the operational highlights. We surpassed 50% enrollment in our phase two trial. We’ve expanded the trial to new sites in the U.S., as well as in Canada. We presented safety data at one of the conferences, and our principal scientist received the Best Researcher Award at the 11th Annual Neurosciences Awards ceremony. We’re also expanding our pipeline. IGC M3 has demonstrated disease-modifying potential on amyloid aggregation, oxidative stress, and also on mitochondrial dysfunction. TGR 63 has shown that it can suppress tau fibril formation as well as disrupt A beta plaque aggregation. Subsequent to the second quarter, IGC 1C was shown to block zinc-mediated tau condensates and promote disillusion.

This is something that’s also disease-modifying and disease targeting. I want to talk a little bit about our phase two trial. The trial is called CALMA, and as we mentioned, 76% have agitation in Alzheimer’s. Our preclinical data from our phase one study, and preclinical meaning a lot of the studies on cell lines as well as mouse data, showed that this particular combination in IGC 81 had the potential to reduce A beta aggregation, reduce phosphorylation of tau, which is what leads to tangles, and also mitochondrial dysfunction. These are hallmarks and very important targets for the disease. We were able to show in preclinical that our formulation targets these. Now, in phase one, when we did our safety study, what we discovered is that it also reduces neuropsychiatric symptoms. One of the neuropsychiatric symptoms that it targets and it reduces is agitation.

We decided in phase two, rather than focusing on the disease itself, we would focus on agitation. There is, as I said earlier, a major unmet need for a therapy that targets agitation. Our long-term goal remains to run a trial and to expand IGC 81 into a disease-modifying therapy. Phase two, the CALMA trial, is 146 participants that need to finish the trial. Our primary objective is to look at agitation. Currently, we have completed over 50% enrollment. We continue to accelerate the enrollment. This is something that we’re hoping to get done, certainly in the first half of next year. The CALMA trial has expanded considerably, and we are in Florida. We are doing the study in New York. We have sites in Maryland. We have sites in Virginia. We have sites in upstate New York.

We’ve also expanded the trial to Toronto and also to Montreal. We have a very, very good set of clinical sites that are running our trial. I mentioned earlier that we believe that we’ve de-risked the molecule. We did an interim analysis on the first 30 patients. What we discovered was that our medication reduces agitation in the first two weeks. We saw a dramatic drop in agitation score compared to placebo. The existing medication takes between 6-10 weeks to actually start having an impact. Ours has an impact within two weeks. This is something that is a very, very important differentiator between an existing study and what we have. As I mentioned earlier, preclinical, we were able to show that the medication reduces phosphorylation of tau, which is what leads to tangles. It’s also able to reduce A beta monomers.

Essentially, it’s able to disrupt the formation of plaque. This is something that’s a very strong indicator that the molecules or our therapy is disease-modifying. This is something that we want to be able to test. Our enhanced platform, we have five platform drugs. IGC 81 is the most advanced, and it targets neuropsychiatric symptoms. It also, based on preclinical data, has the potential to target AD pathology or Alzheimer’s pathology. IGC LMP is something that we’ve created in-house, and what we expect to do is show that it is bioequivalent to IGC 81. The TGR 63 platform targets plaques, and it’s aimed at early to moderate Alzheimer’s patients. IGC M platform targets plaques, and it’s also a GLP-1 modulator. IGC 1C, this is another platform drug, and this platform targets tau and is also a GLP-1.

This is an important one because this particular platform does not take the traditional targeting plaques route. It takes a slightly different route in that it targets tangles. We have extensive preclinical data that we announced this year. IGC 1C, as we said, is something that is able to target tau and also target tau condensates. IGC M3 is something that reduces A beta aggregation. It reduces oxidative stress, and it also targets neuroinflammation. We were able to show in preclinical data that it improves mitochondrial function. It is a molecule that can broadly target the disease pathways. TGR 63 is something that targets beta amyloid, and also it is another one that also targets tau pathology. We have a robust pipeline with IGC 81, the most advanced, and we have all these other molecules that are also up and coming and that we are working on talk studies.

We’re working with these molecules. We’ve also developed an AI-based diagnostic platform, and we call this MINT-AD. What we’ve essentially done is downloaded data sets from around the world, and these are massive data sets that contain longitudinal studies as well as deep studies and they’re multimodal studies. Some data sets are clinical, some are biomarkers, others might be omics, others are genetic. There’s also PET scans, MRI scans. What we’ve done is we’ve taken all this data, and we’re training a multimodal interpretable transformer that’s specifically aimed at Alzheimer’s. This particular model that we’re creating is very important, and here’s what it can do. It can stratify individuals with risk factors.

For example, it can take a patient and say, "This particular patient has a low probability of getting Alzheimer’s or has a moderate or a high risk of getting Alzheimer’s." The second thing it can do is that based on whether the individual is at low, moderate, or high, it can predict cognitive decline two to five years out. We are developing this as a doctor’s tool. This is something that we hope to be able to deploy with doctors, especially in low-resource areas where neurologists may not be available, and general practitioners can use this tool to diagnose a patient and be able to show that patient that the patient is at a certain risk level and also be able to say that, "Look, two years from now or three years from now, this is what could happen." You need to take some intervention.

There are lots of studies that show that non-pharmacological interventions are available, and studies have been able to show that such interventions can delay the onset of dementia. We think this is very powerful. There are, as I mentioned earlier, over 400 million people with AD pathology in their brains that are at risk for getting Alzheimer’s. An early diagnosis, especially without PET scans, which is the gold standard of diagnosing Alzheimer’s, if this can do it based on medical history, lifestyle, where the individual lives, all the various risk factors, then we can do something about helping these 400 million people decrease their risk. I want to give you a quick financial summary. We are very focused on minimizing dilution and maintaining a clean cap table. We’ve applied for many grants.

We’re also in the semi-final round of a $1 million prize that’s being awarded for an AI program that can advance Alzheimer’s research. This semi-final round is in the first week of December. We’ve renewed our $12 million line of credit, and we’re funding our business through very selective capital raises. Our focus is to get to the finish line with phase two. We’re also focusing on capital deployment, on efficiently advancing our drugs through the clinic at a very low cost per patient. We’re not using very high-end CROs for the trial. We’ve built an internal team that’s very focused on cost. We’ve got multiple pending clinical milestones, both to reduce cost of capital but also aligned with investors. Number one will be the finishing of this trial, which we expect to finish in the first half of next year.

In terms of upcoming milestones, our focus is on completing the CALMA phase two trial, continuing with IND enabling studies for the expanded pipeline, and expanding IGC 81 as a disease-modifying treatment with a new phase two trial. The fourth is to deploy MINT-AD with doctors and start getting a great deal of feedback so that we can improve that model. Hopefully, that model can help individuals that have amyloid or have Alzheimer’s pathology and are at risk for Alzheimer’s but do not yet have the disease. We are very excited about next year. We are very focused on getting these milestones done, and we believe that achieving these milestones will greatly enhance shareholder value. Thank you, everyone, for supporting us through this journey, and we are hoping we are getting closer to the finish line as far as CALMA phase two trial is concerned. Thank you.

Operator, please now open the call for the question and answer session. Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question for today is from Ed Wu with Ascendiant Capital. Yeah. Congratulations on all your progress. Definitely looking forward to completing your trial next year in the first half. My question is, do you anticipate having another interim data analysis before then? Hi, Ed.

Thank you for that question, and thank you for being on the call. No, we do not expect to have another readout. At this point, we are focused on just completing the trial and focusing on the final readout. Great. It looks like you recently sold your white label business. Was there any rationale for why you guys did that? Ed, we did not sell the white label business. That business continues. What we did was to strategically divest our non-performing or our non-core Vancouver manufacturing facility. We did that in September of 2025 for a fair value of about $2.7 million, which was the primary driver of the $1.1 million non-cash profit that we reported as other income. There are essentially three reasons we did it. One was that we eliminated approximately $600,000 in annual operating expenses. That is money that can be focused more on the trials.

Second is that it allows the company to redirect resources and, importantly, management attention entirely to accelerating the CALMA trial and also advancing some of our other small molecule assets like TGR and IGC M3. You mentioned the white label business. What we did was to secure long-term preferential supply rights, and we also got a contingent 10% share of any future sale proceeds. That ensures that our white label business can continue, but we do not have the management burden of operating a facility. We have some upside in the event that the current owners decide to sell that facility at a future date. We have 10% upside in terms of whatever they get, we would get 10%. It was a very strategic move. We did not get rid of our white label business.

That business will continue, but it’s just that we got rid of the management burden of operating the facility. Great. Thanks for clarifying that for me. My last question is on IGC 81, the CALMA trial. You have a number of sites in Canada. Is there any plans to run to get Canadian approval in parallel with you trying to get FDA approval? Yes, Ed. That is the plan. We are running the trial in the U.S., as you know. We’re also running it in Canada, and we’ve been approved by Health Canada for running the trial there. Our medication and the manufacturing, everything is in front of them. The idea would be to seek approval in both of these places, both in the U.S. as well as in Canada. Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.

Thanks, Ed. Your next question for today is from Adam Snyder with Sandtree Capital. Hey, guys. Thanks for taking the question. The newly passed government funding bill contained language that impacted the hemp industry. Should investors expect any impact on your phase two trial there? Adam, that’s a great question, and thank you for asking that. That bill came out of left field and gave me several nights of several sleepless nights. No, we do not expect any impact on the CALMA trial. Our focus is, as you know, on pharmaceutical development and FDA approval, and it’s not on the consumer hemp market. Investors should really consider two factors with that bill and its impact on us.

The first is that IGC 81 is an investigational new drug that’s currently in a trial, and it’s under very rigorous oversight with regulatory bodies, both in the U.S. as well as in Canada. The drug is also manufactured and it’s administered under controlled and regulated clinical protocols. The recent bill that was passed targets the consumer hemp market. It does not impact the regulatory pathway for prescription drugs like IGC 81. The second thing that investors should keep in mind is that the legislation is scheduled to take effect in approximately one year. We are highly focused on completing patient enrollment. It’s a key financial year 2026 priority for us, and we’re moving rapidly towards completion of the CALMA trial. We expect to finish well before the effective date.

The trial’s completion and the primary data readout are fully insulated from any impending regulatory changes. Got it. Okay. That’s very helpful. Thank you. That’s all for me. Your next question is from James Malloy with Alliance Global Partners. Hey, guys. Thanks for taking my questions. On the CALMA trial, I know that you had back in September talked about expanding to 13 more sites to a total of 35. Are all 35 up and running currently and past the 80 patients as well? Any anecdotal sort of stories or any anecdotes from the trial on sort of how enrollment’s going and with any challenges to enrollment or positives for enrollment? Thanks, Jim. Thank you for that. Thank you for being on the call. And that question, yes, we did announce that we had surpassed 50%.

We’re clearly significantly further along now, and we hope to give the market an update. We did expand the number of sites, and we’ve expanded the number of sites in the U.S. Those sites are coming along, and they’re coming on board. It takes between two to three months to get a site up and running because of all the regulatory procedures that you have to go through to get it through the IRB and all the filings with the FDA. There are several rounds of training where there is protocol training as well as this training for the raters. All that is going on. We’re very encouraged because the number of patients that we’re signing up has increased considerably. A lot of it also has to do with the advertising that we’re doing online as well as geotargeting the sites.

We are looking for patients in areas where we have our sites. What we do is once we are able to recruit them, we send them to the site for further evaluation. That program on social media is proving to be very successful. I am very encouraged by how many patients we are signing up. I will give you an example. We have sort of gone from signing up four patients a month to, I think, last month we had 14. It is a considerable acceleration in the trial recruitment. Maybe a follow-up. Could you walk us through sort of what we should anticipate here in this December potential $1 million award for the MINT program? Yes, Jim. I did not mention that, but the ADDI, which is the Alzheimer’s Drug Discovery Initiative, has essentially created a very large depository of databases from all around the world.

They had a contest where they invited, and I think about close to 300 people were involved, 300 contestants were involved. We were chosen as the final, we were chosen into the semifinal round, which is a group of 10. We are expected to present our idea for accelerating Alzheimer’s research. This semifinal round is on December 5. We expect to be presenting to a panel of judges essentially our idea for how to accelerate Alzheimer’s trials and to accelerate Alzheimer’s research using artificial intelligence. I think it’s a great testament to my team. We’ve received two other awards from the National Institute on Aging. We’re very encouraged that we’re getting this recognition for the work that we’re doing. Great. Thank you for taking the questions. Thank you, Jim.

We have reached the end of the question and answer session, and I will now hand the call over to Ram for closing remarks. Thank you, everyone. Thank you very much for joining us on this call. We are looking forward to a very, very strong six months where we are expecting to finish the trial. We are expecting to get MINT-AD, our AI platform, up and running and start to beta test that. Wish us luck in the semifinal round with the $1 million prize. We hope to make it into the top three finals, which will be decided on December 5th. We are very encouraged by that as well. We are looking forward to a very, very strong close to financial year 2026. Thank you very much. This concludes today’s conference, and you may disconnect your lines at this time. Thank you for your participation.