IGC Pharma, Inc.

IGC Pharma, Inc.

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Q3 FY2025 · Earnings Call TranscriptNovember 17, 2025

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, Rosalyn Christian with IMS Investor Relations.

Rosalyn Christian

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. With that, I would like to turn the call over to management.

Please go ahead, Ram.

Ram Mukunda

Thank you, everyone, for joining us on our 6-month update. As all of IGC has 5 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 IGC-81 is the most advanced one.

It is in a Phase 2 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're going to talk about that as well. Before we get into what we're 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 don't have any of the symptoms yet, but they are all at risk for getting Alzheimer's. Now of the 55 million that have been diagnosed with Alzheimer's, about 76% have or experience agitation.

Current treatments for agitation, there's only one that's been approved by the FDA, comes with a black box warning and takes about 6 to 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, but 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 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 1 trial, and we found that it actually helped the patients. In our Phase 2, 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, which 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.

2026, I just want to give you some of the operational highlights. We surpassed 50% enrollment in our Phase 2 trial.

We've expanded the trial to sites in the US, to new sites in the US, as well as in Canada. We presented safety data at one of the conferences, and our principal scientist was received the Best Researcher award at the 11th Annual Neurosciences Award 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 Abeta plaque aggregation. Subsequent to the second quarter, IGC-1C was shown to block zinc-mediated tau condensates and promote dissolution.

This is something that's also disease-modifying and disease-targeting. I want to talk a little bit about our Phase 2 trial.

The trial is called CaLMi. As we mentioned, 76% have agitation in Alzheimer's.

Our preclinical data from our Phase 1 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 Abeta 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 our formulation targets these. Now in Phase 1, when we did our safety study, what we discovered is that it also reduces neuropsychiatric symptoms, and one of the neuropsychiatric symptoms that it targets and is and it reduces is agitation.

We decided in Phase 2, rather than focusing on the disease itself, we would focus on agitation. There is, as I said earlier, there is 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 2, the CaLMi trial is 146 participants that need to finish the trial.

Our primary objective is to look at agitation. Now currently, we have completed over 50% enrollment.

We continue to accelerate the enrollment, and so this is something that we're hoping to get done in, certainly in the first half of next year. The CaLMi 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, and what we discovered was that our our medication reduces agitation in the first 2 weeks.

We saw a dramatic drop in agitation score compared to placebo. The existing medication takes between 6 to 10 weeks to actually start having an impact.

Ours has an impact within 2 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 Abeta monomers, essentially the 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, and this is something that we want to be able to test. Our enhanced platform, we have 5 platform drugs.

IGC-81 is the most advanced, and it targets neuropsychiatric symptoms, and it also, as based on preclinical data, has the potential to target AD pathology or Alzheimer's pathology. 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 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-C, 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 doesn't 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 Abeta aggregation, it reduces oxidative stress, and it also targets neuroinflammation.

We were able to show in preclinical data that it improves mitochondrial function. It's a molecule that can broadly target the disease pathways.

TGR-63 is something that targets beta-amyloid, and also it's another one that also targets tau pathology. We've got a robust pipeline with IGC-81 the most advanced, and we've got all these other molecules that are also up-and-coming, and that we're working on tox studies, we're working with these molecules.

We've also developed a AI-based diagnostic platform, and we call this Mint AD. What we've essentially done is downloaded datasets from around the world, and these are massive datasets that contain longitudinal studies as well as deep studies, and they're multimodal studies, some datasets 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've that we're creating is very important, and here's what it can do.

It can stratify individuals as 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 2 to 5 years out. This is We're developing we're developing this as a doctor's tool.

This is something that we hope to be able to deploy with doctors, and especially in low-resource areas where neurologists may not be available, and general practitioners can use this tool to diagnose a a patient and be able to show that patient that the patient has is at a certain risk level, and also be able to say that look, 2 years from now or 3 years from now, this is what could happen, and so 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. It is There are, as I mentioned earlier, over 400 million people with AD pathology in their brains that are at risk for getting Alzheimer's, and 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 in the semifinal round of a $1 million prize that's being awarded for an AI program that can advance Alzheimer's research.

This semifinal 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 2. We're also focusing on capital deployment on a very on efficiently advancing our drugs through the clinic at a very low cost per patient.

We we are 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 CaLMi Phase 2 trial, continuing with IND-enabling studies for the expanded pipeline, and expanding IGC-81 as a disease-modifying treatment with a new Phase 2 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 don't yet have the disease. We're very excited about the 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're hoping we're getting closer to the finish line as far as CaLMi Phase 2 trial is concerned.

Thank you. Operator, please now open the call for the question-and-answer session.

Operator

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 Woo with Ascendiant Capital.

Edward Wu

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?

Ram Mukunda

Hi, Ed. Thank you for that question, and thank you for being on the call.

No, we don't expect to have another readout. At this point, we're 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 didn't sell the white-label business. That business continues.

What we did was to strategically divestiture 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.

Now there are essentially three reasons we did it. One was that we eliminated approximately $600,000 in annual operating expenses, so that's 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 CaLMi 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 ensured that our white-label business can continue, but we don't 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 a facility.

Edward Wu

Great. Thanks for clarifying that for me.

My last question is on IGC-81, the CaLMi trial. You have a number of sites in Canada.

Is there any plans to get Canadian approval in parallel with you trying to get FDA approval?

Ram Mukunda

Yes, Ed. That is the plan.

We're running the trial in the US, 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 US as well as in Canada.

Edward Wu

Great. Thanks for answering my questions, and I wish you guys good luck.

Thank you.

Ram Mukunda

Thanks, Ed.

Operator

Your next question for today is from Adam Snyder with San Tree Capital.

Adam Snyder

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 2 trial there?

Ram Mukunda

Adam, that's a great question, and thank you for asking that. That bill came out of left field and gave me several sleepless nights.

No, we do not expect any impact on the CaLMi trial. Our focus is, as 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 US 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 1 year.

We are highly focused on completing patient enrollment. It's a key financial year '26 priority for us, and we're moving rapidly towards completion of the CaLMi 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.

Adam Snyder

Got it. That's very helpful.

Thank you. That's all for me.

Operator

Your next question is from James Malloy with Alliance Global Partners.

James Malloy

Hey, guys. Thanks for taking my questions.

On the CaLMi trial, I know that you had, back in September, talked about expanding to 13 more sites for a total 35. Are all 35 up and running currently?

You're past the 80 patients as well. Any anecdotal sort of stories or any anecdotes from the trial on sort of how enrollment is going and any challenges to enrollment or positives for enrollment?

Ram Mukunda

Thanks, Jim. 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 US. Those sites are coming along, and they're coming on board.

It takes between 2 to 3 months to get a site up and running because of all the regulatory procedures that you have to go through. You get it through the IRB and all the filings with the FDA.

Then there's 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 were 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're looking for patients in areas where we have our sites, and 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'm very encouraged by how many patients we're signing up. I'll give you an example.

We've sort of gone from signing up 4 patients a month to I think last month we had 14. It's a considerable acceleration in the trial recruitment.

All right, great. Maybe a follow-up.

Could you walk us through sort of what we should anticipate here in this December potential million-dollar award for the Mint program? Yes, Jim.

I didn't mention that, but the ADDI, which is the Alzheimer's Drug Discovery Initiative, they've actually 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 300 contestants were involved.

We were chosen into the semifinal round, which is a group of 10, and we are expected to present our idea for accelerating Alzheimer's research. The semifinal round is on December 5, we expect to be presenting to a panel of judges basically our ideas of 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 of Aging, we're very encouraged that we're getting this recognition for the work that we're doing.

All right,

James Malloy

great. Thank you for taking the questions.

Ram Mukunda

Thank you, Jim.

Operator

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.

Ram Mukunda

Thank you very much for joining us on this call, and we're looking forward to a very, very strong 6 months where we're expecting to finish the trial. We're expecting to get Mint AD, our AI platform, up and running, and start to beta test that.

Wish us luck in the semifinal round for the $1 million prize. We hope to make it into the top three finals, which will be decided on December 5th.

We're very encouraged by that as well. We're looking forward to a very, very strong close to financial year '26.

Thank you very much.

Operator

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.