All right. Hello everyone. Good morning. Thank you all for continuing to join us throughout the day here at the Lytham Partners Spring 2026 Investor Conference. Again, my name is Robert Blum, Managing Partner here at Lytham. Up next, we welcome Lisa Conte, Chief Executive Officer of Jaguar Health. As a reminder, Jaguar trades under the ticker symbol JAGX on the Nasdaq. Lisa, thank you as always for your participation. The floor is now yours. Thank you, Robert. Of course, this is my favorite conference. Th ank you for inviting us again. As you accurately said, we are a public company, here's our forward-looking statements, which we'll dispense with quickly here. I did want to mention that Jaguar has a wholly owned subsidiary, Napo Pharmaceuticals, I might use the names Jaguar and Napo interchangeably throughout the presentation. For those who might be introduced to this company for the first time today, let's just give the quick thumbnail sketch of what we do. We do all our drug discovery from our basic enabling technology of leveraging the knowledge of shamans and healers in rainforest areas to do more efficient drug discovery and development. That has been a passion for the past 35 years, it has led to the development of a first-in-class FDA-approved product. The active ingredient is known as crofelemer, and the commercial product is Mytesi, and it is approved for AIDS-related diarrhea. Crofelemer is also the active ingredient in a conditionally approved product by the Center for Veterinary Medicine of the FDA for dogs, for chemotherapy-induced diarrhea in dogs. Two FDA products that have come from that process. I do want to say that all our drug discovery is from plants. Our products are plant-based. They are prescription products. They are organic. They are fair trade. They are sustainably harvested, and they are the only oral products approved by the FDA under botanical guidance. Under botanical guidance, there is no practical pathway to bring a generic to market. Even though we have over 150 patents issued and a patent strategy that continues to extend patents as traditionally in the pharmaceutical industry, we essentially have exclusivity to infinity and beyond, which is quite powerful in our business development discussions when you're determining the terminal value of a particular franchise. What this presentation is all about is, the key thing to remember is this is a transformative moment in the company, and it's coordinated with sharp strategic focus, strong, important focus of our resources on the R&D side. This is why. The power of crofelemer is that it is a pipeline within a product. You can see the first indication here that is approved for AIDS-related diarrhea. Multiple follow-on indications for Mytesi, for the commercial product that is approved. We can't do everything. The transformative moment has come about in the beginning of 2026, the top of the year, and throughout the rest of the year. That is a commercial out-license deal that we did for Mytesi and Canalevia-CA1 that provides up to $38 million in non-dilutive funds that we are using to fuel our sharp strategic focus on the research and development side. I'm going to go through these bullet points because they're important one by one. It was an $18 million upfront payment for the license to Mytesi. Mytesi annual sales have been around $12 million-$13 million. There's an additional $20 million that can come from milestone and other future payments. Again, non-dilutive funds that we can utilize to fund our pipeline. We continue to be the manufacturer of crofelemer, and that is at a profit. There's a margin on top of that. In addition to the funds that we got on closing, there was a couple of million dollars of other funds, all disclosed in our Q that we just filed, that had to do with supply and inventory purchases of the product. Our near-term focus, our sharp strategic focus, is on our rare disease program of intestinal failure. In particular, we are focused on our late-stage development from MVID, Microvillus Inclusion Disease, for an NDA filing in mid-2027 based on data that we have in hand now and that will continue to come out throughout the balance of 2026. MVID intestinal failure is a stepping stone to another program that we have going on in clinical trials in short bowel syndrome intestinal failure. That's a blockbuster market that is expected to reach over $8 billion by third-party analysis. The MVID market itself is estimated at anywhere between $50 million and over $1 billion, depending on who's doing the analysis. There is convergence of all these catalysts, regulatory, clinical, and business development on our intestinal failure program throughout the next six, 12, and 18 months, ultimately resulting in a new drug application targeted for mid-2027. The key thing about crofelemer for the rare disease program is it's a different product than Mytesi. It's the same active ingredient. We benefit from thousands of patients, tens of thousands of patients who have taken it commercially, thousands of patients who have been in blinded clinical trials with no adverse events, no difference between placebo and crofelemer. Safety is a huge hallmark of the active ingredient, but it's in a different formulation that is medically relevant and required for intestinal failure. You can't put a pill in the administration to these patients. It would go right through with rapid transit time and land in the toilet bowl. It's a highly concentrated liquid formulation, therefore, a different product, a different NDA, and therefore, a different pricing and business model associated with rare diseases. The key thing is that these development efforts are being funded by the non-dilutive dollars of the deal that we closed in January of this year, the license deal. All strategically related together. What is MVID? This is intestinal failure is the umbrella indication. MVID is the very near-term targeted NDA with a stepping stone to short bowel syndrome intestinal failure. MVID, if you can see me, or Microvillus Inclusion Disease. The microvilli in the intestine are like little fingers, and they absorb the nutrients of life, the protein, the carbs, vitamins, minerals, et cetera. In microvillus inclusion disease, they're inverted, so they can't absorb. The patient has a fully intact intestine, but it's not functioning. If they're not diagnosed immediately when they're born, they die. If they are diagnosed, they go on parenteral support, total parenteral nutrition, IV nutrition, about 20 hours a day, seven days a week, for the rest of their life. Now, TPN is necessary for life and remarkably toxic at the same time. It is considered the second most toxic thing we do to patients after chemotherapy. There is a very serious risk to liver and kidney disorders, cognitive dysfunctions. The patients, the children, never quite land on an appropriate growth curve. They have massive diarrhea. It's basically a lethal natural history, and the children have a failure to thrive, and this is with the life-sustaining TPN that they're on. The key things that you're looking for in an endpoint in a clinical trial, the key thing that we're looking for with treatment with crofelemer, is a reduction in the TPN, the parenteral support, the total parenteral support for the patient. That's the key primary endpoint. In addition, enhanced urine output shows that the patient is absorbing some of the nutrients of their own. Reduction in stool volume and improvement in stool formation, of course, that not only has clinical benefits, but quality-of-life benefits. The key things that you hear from the treating physicians, from the entire caregiving team, this is their entire life, so it's not only family, it's nurses, nurse practitioners, nutritionists, as well as the healthcare professionals. If you could reduce the TPN needs even by 5% or 10% and give the patient the opportunity, for example, to not be on TPN for 20 hours a day, but to a point where it could be administered mostly at night, so that the patient could have enough relief and go to school, to go swim, some sort of activity. They can start to have some sort of a life and not just exist, but actually have some sort of childhood. Of course, on a clinical growth curve as well. This is dense, but this is important. I'm going to go through it. These are the results that we've seen to date, the proof of concept results that were presented last year at the European Society for Paediatric Gastroenterology, Hepatology and Nutrition meeting, ESPGHAN, and has been accepted for an update at ESPGHAN this year, which is going to be in June in France. Last year, what we found in both an MVID and a paediatric intestinal failure short bowel syndrome patient, that we were able to reduce PS needs, parenteral support needs, by 37% and almost 16%, respectively. This was groundbreaking, unheard of. It was a standing ovation at the medical conference where it was presented. In addition, crofelemer treated patients had reduced stool volume. They had better formation in their stools. All indicators of improved nutrition oral absorption. Interestingly, now, these were investigator-initiated patient trials, these were not blinded trials. The patient, after three months, was discontinued from crofelemer and relapsed so quickly that they had to immediately be put back on crofelemer. The drug withdrawal scenario is one of the most powerful indicators of product performance, product benefit. This year, in the follow-up presentations, the investigator-initiated patient, the patient with 37% reduction, has now been on the product for 15, 16 months, continues to maintain at least that level of reduction of parenteral support, and also no safety issues whatsoever. That patient is thriving. There is a second paper abstract that has been accepted, and this is a second patient. This is an expanded access patient in the United States. The infant was born and diagnosed with MVID. Because the enrollment criteria for our ongoing blinded trial, which I'll talk about in a moment, requires that the patient be one year old, the patient couldn't enroll in that clinical trial. With FDA individual IND under expanded access, that patient, at three months of age, went on crofelemer. The patient is now nine months old, thriving. At the, I believe 30% or 40% growth level in the normal growth curve for a nine-month-old. We have a beautiful picture of this bouncing baby. I believe the baby herself, with her parents, is going to be coming to the conference. It essentially has saved the life of that baby. This is the first time an infant has been treated so early with crofelemer. The key thing is this is an ultra-rare disease. There's about 200 patients that are known around the world. Between our blinded clinical trial, which is ongoing now and has six patients enrolled, fully enrolled, The two patients that we have in the expanded access and the investigator-initiated, we believe we're treating about 4% of the world's patient population. We've had discussions with both the FDA and the EMA. We believe that that is going to be, based on those discussions, sufficient to file for the new drug application for intestinal failure in MVID. As I said, which is important for these patients in and of themselves, and a stepping stone to the larger short bowel syndrome intestinal failure market. Intestinal failure and short bowel syndrome, same thing. The patients are on parenteral support 20 hours a day, seven days a week. In this case, it's based on surface area because they have a short bowel syndrome. Ours is 25 ft. Theirs may be 5 ft or less, so they don't have sufficient surface area to absorb the nutrients of life. The key convergence of catalysts, and as I wrap up this presentation, this is a transformative moment for the company, driven by the license deal that brought in non-dilutive dollars in January. This is coordinated with our sharp strategic focus and the efficient utilization of those non-dilutive resources and dollars to focus on our rare disease program, our intestinal failure program. We'll have the data that we just talked about presented next month at ESPGHAN. We have our MVID patients in our blinded trial. Those six patients that are continuing now where they move from the blinded portion to the treatment only, and that's the powerful opportunity to show the benefit of the product. No safety issues. With that data in hand, we'll file for Breakthrough Therapy designation with the FDA, which would give us approval in potentially four months from filing. We expect to have the fileable data for MVID by the end of this year, file the new drug application in mid-2027, that would be at the same time that we would complete a blinded trial that's ongoing right now for short bowel syndrome intestinal failure, which is the $8 billion market, as a stepping stone from the ultra-rare market from MVID. With that, I will conclude my presentation. I think that is the key message I wanted to deliver. Fantastic. Lisa Conte, thank you as always for your participation in the conference here. Thank you to everybody, of course, for watching. If there are any questions or you'd like to schedule a meeting with management here, send me an email. That's B-L-U-M, blum@lythampartners.com. Of course, to learn more about Lytham, make sure you visit our website or follow us on LinkedIn. We hope everyone has a great rest of the conference. Great day. Again, Lisa, thanks so much. Thank you.
Loading workspace