Jaguar Health at Lytham Partners: Strategic Insights on Crofelemer

On Tuesday, 30 September 2025, Jaguar Health (NASDAQ:JAGX) presented at the Lytham Partners Fall 2025 Investor Conference. The company highlighted its strategic focus on expanding the use of its FDA-approved drug, crofelemer, into new medical areas. While positive developments were shared, including potential corporate partnerships, challenges such as funding timelines remain.

Key Takeaways

• Jaguar Health is actively pursuing new indications for crofelemer, particularly in cancer therapy-related diarrhea and rare diseases.
• The company is seeking corporate partnerships to support non-dilutive funding for further development.
• Recent orphan drug application for metastatic breast cancer is expected to open up new partnership opportunities.
• Investigator-initiated trials showed promising results in reducing parenteral support for MVID patients.
• Jaguar Health received a $250,000 grant from the FDA for research on chemotherapy-induced diarrhea in dogs.

Financial Results

• Mytesi Sales: Sales are growing at approximately 5% per year, driven primarily by Mytesi.
• Grant Award: The company was awarded a $250,000 grant from the FDA’s Center for Veterinary Medicine, although the timing of fund access is uncertain.
• Market Opportunity: The short bowel syndrome market is estimated at $4.5 billion, and the chemotherapy-induced nausea and vomiting market is approximately $4 billion.

Operational Updates

• Cancer Therapy-Related Diarrhea: An orphan drug application was filed for metastatic breast cancer patients. A treatment trial is expected to be completed in 2026, with a supplemental NDA filing to follow.
• Intestinal Failure: Four phase 2 studies are ongoing, with data showing significant reductions in parenteral support for MVID and short bowel syndrome patients. An FDA meeting is scheduled to discuss expedited approval pathways.
• Canalevia CA1: A confirmatory trial for chemotherapy-induced diarrhea in dogs is in progress.

Future Outlook

• Cancer Therapy-Related Diarrhea: Plans are in place to complete a treatment trial for metastatic breast cancer patients by 2026.
• Intestinal Failure: The company aims to expedite approval for MVID and subsequently pursue approval for short bowel syndrome within 18-24 months.
• Business Development: Jaguar Health is prioritizing partnerships with companies interested in rare diseases to secure non-dilutive funding.

Q&A Highlights

• Orphan Drug Designation: The designation for metastatic breast cancer is expected to enhance partnership opportunities in rare diseases.
• Cancer Indication in Dogs and People: Experiences with Canalevia CA1 in dogs are seen as analogous to the human market, with potential support from cancer drug manufacturers for crofelemer marketing.

For more details, readers are encouraged to refer to the full transcript below.

Full transcript - Lytham Partners Fall 2025 Investor Conference:

Roger Weiss, Vice President, Lithium Partners: Hello everyone, and thank you all for joining us during the Lithium Partners Fall 2025 Investor Conference. My name is Roger Weiss, and I’m a Vice President here at Lithium. Today, we are joined by Lisa Conte, CEO at Jaguar Health, who will be taking us through the company slide presentation, followed by a short Q&A session. Please note that Jaguar trades under the ticker symbol JAGX on the NASDAQ. Lisa, welcome to the Lithium Fall Conference.

Lisa Conte, CEO, Jaguar Health: Thank you, Roger, and I appreciate being here. This is my favorite conference of the year. Let’s kick it off. I know there’s some, probably, hopefully, some new people, but some older people. I will just give a quick reminder of who we are. We are a public company, so we’ll dispense with the forward-looking statements. I do want to say this is such an interesting time because pharmaceutical development, drug development is a long process, and sometimes you don’t have anything to say for a long period of time when clinical trials are going on and the stock price will sort of languish. You know, you think, oh, they’re just doing the same thing. What’s going to be different? That’s the definition of crazy. What’s equally crazy is when you do something dramatically different and you think that the answer, the impact is going to be the same.

This is an era of catalysts and inflection points for the company, many that have recently occurred and some that have very, very recently occurred and some that are about to come. That’s what we’re going to talk about today, and that’s the theme. Just to remind everybody, we do all our drug discovery from plants that are used traditionally in tropical areas, and we do have a product approved. Crofelemer is approved for humans for the specialty indication of chronic diarrhea, people living with HIV/AIDS, and that is under the brand name of Mytesi. What’s interesting about Mytesi is that it is natural, plant-based, organic, sustainably harvested, fair trade, and it’s an FDA-approved drug. Very importantly, it’s the only oral drug approved under botanical guidance, where there is no practical pathway to bringing a generic to market.

Even though we have the full patent strategy, comprehensive strategy, 156 or so patents issued, we essentially have exclusivity to infinity and beyond, a huge value when we think about not facing a patent cliff and the value to potential corporate partnerships that we are in discussions with. Crofelemer is also approved under the brand name Canalevia CA1, conditionally approved for chemotherapy-induced diarrhea in dogs under the Center for Veterinary Medicine. We’ll talk about the small animal health program. Really, the main focus of the company is the human marketplace. What’s lovely about crofelemer is it keeps us fully busy as a risk-reduced development company, development stage company. As I mentioned, it’s approved for the specialty market. Another word for specialty is relatively small market for HIV-related diarrhea. Why do we do that? First, we were fast-tracked and priority reviewed by the FDA.

There’s great value in getting a product on the market. First of all, safety, manufacturing, the two most common reasons why new drug applications fail or get pushed back. We already have that done as we look at new indications. Also, it’s a first-in-class, paradigm-shifting mechanism of action. The opportunity to be out there educating and promoting and learning how to have that resonate with healthcare professionals across the board, including patients, a different way of treating and potentially curing disease. We are out there doing that now with the first indication, and of course, that will carry on to other indications as well. What are the other indications? There’s about seven here. We can’t do them all. Crofelemer is truly a pipeline within a product.

The two that we’re going to talk about that have amazing recent catalysts and upcoming catalysts are cancer therapy-related diarrhea, which has completed a phase 3 clinical trial, and in rare disease, orphan indications of intestinal failure with short bowel syndrome, and microvillous inclusion disease (MVID), an ultra-rare disease. Let’s jump into that. The recent catalysts have been in the intestinal failure area. We have four phase 2 studies going on, two of which are investigator-initiated, the first of which has already put out data in a public forum and will continue to put out data in a public forum, which is really groundbreaking, remarkable, and we’ll be talking more about that. In the cancer area, we do have statistically significant results in a prospectively defined subgroup of breast cancer patients that was presented at the San Antonio Breast Cancer Symposium and the MASCC Symposium last year.

The key event that recently occurred this year was a meeting with the FDA to discuss, clarify a pathway to bring this product to approval in an expedited manner. The three key events from that are, number one, file a final study report for that study. Secondly, complete a survey of the relevance of the reduction of diarrhea and the impact on patients today versus a survey that was done in 2018 to support the on-target results. Thirdly, focus on metastatic breast cancer patients as an orphan population because of the greater flexibility in the support, the regulatory support to get an expedited approval. The last thing is, because of the immediate need, get an expanded access patient program going right now for patients who won’t qualify for the additional clinical trials that we’re doing. That’s what we’re going to talk more about. These inflection points, what is the manifestation?

What’s the purpose of all that? To bring in major corporate partnerships, non-dilutive dollars for the expense and the time and the risk reduction that we have brought to these programs, and then to collaborate with the additional resources to really bring these out successfully on an educational, promotional, commercial opportunity. One of the very, very recent events, the catalysts that we have, is we did file the orphan drug application for metastatic breast cancer patients. Let me put this in perspective. Our first phase 3 study, which we completed last year on target, was a very broad, bold trial looking at all solid tumors, prophylaxis, patients on 24 different targeted agents with or without cytotoxic chemotherapy. A big hug to the community trying to bring everybody into the tent. We did not achieve statistical significance.

However, in breast cancer patients, which was about 63% of the patients, we did see statistical significance, and that has been published in a responder analysis. When we went to our FDA meeting, which was in May of this year, we kicked off that meeting with two of our scientific advisory members who are patient advocates. We have formal scientific advisory membership from patient advocates. One of those patient advocates talked about the impact of diarrhea in the context now of targeted therapies. The thing about diarrhea is we’ve all experienced diarrhea. We’ve all had a bad meal, whatever it is. Targeted therapy diarrhea is a completely different situation. We’re talking about four different grades of diarrhea. Grade 2, for example, is four to seven loose, watery stools a day.

What one of the patient advocates pointed out is four to seven loose, watery stools a day, every single day for the rest of your life if you’re in a metastatic situation, probably nine to 18 months if you’re in a curative situation with uncertainty, with the incontinence. Where do you have time in your life for that? In publications of targeted agents, grade 1 and grade 2 side effects are often referred to as tolerable toxicity. Tolerable to whom? That’s just grade 2. There’s a meaningful percentage of patients who are dealing with grade three and grade four, which requires often hospitalization for rehydration, and even in some cases has resulted in mortality. Our second patient advocate, remarkably powerful, this is a metastatic patient, and she is on salvage therapy at this point, putting out 10 to 14 loose, watery stools a day.

She’s been a survivor now for over 10 years. She looked at her husband and she said, this is it. You know, I’m going off this therapy. This is not living. This is just surviving and barely surviving. She received an off-label prescription for crofelemer, which of course the company had nothing to do with. Within 48 hours, she was normal, which was eight months before the FDA meeting. Her very powerful message was, "Hey, this is a product that’s already on the market. No safety issues." This is her speaking, "I was at the San Antonio Breast Cancer Symposium. I saw a publication. I saw a poster on how this product worked in breast cancer patients.

Why can’t all patients have the opportunity to have this product, to be appropriately educated and promoted about it, and to have the opportunity to have it reimbursed?" That sort of kicked off the discussion of what is a pathway to provide the opportunity to get the label for Mytesi expanded, get a supplemental NDA, and get this product to the first set of cancer patients as quickly as possible. Long story to say, we ended up filing a drug application for an orphan indication of metastatic breast cancer, and in particular, breast cancer that has metastasized to the brain, which is a population that has already shown success in designation as a separate orphan disease by the FDA. However, we will be moving forward with a treatment trial that includes all metastatic breast cancer patients.

We expect to complete that in 2026 and file a supplemental NDA shortly thereafter and get this product out to at least the first population of cancer patients as quickly as possible. This is a program that we’ve had going on now, I guess it’s close to two years, Make Cancer Less Shitty. It’s primarily a digital program and really in a non-branded way to focus on all the different side effects associated with, in particular, targeted cancer treatment, which, as I mentioned, for a metastatic patient, they’re on for the rest of their life. There’s about 21 different unmet needs. One of the patient advocates last year referred to it as the pebble in a shoe. You know, could you live with the pebble in your shoe for a short period of time? Of course. For the rest of your life, 21 different pebbles.

This is really a focus on not just keeping the patient alive, but giving the patient their life back. That’s what Jaguar Health is committed to, particularly with this first indication that we’re looking for in the cancer market, supportive care, management of diarrhea. These are some of the agents that were in our clinical trial, and you can see the rates of diarrhea here. These are agents that patients are on every single day. That insult to the gut is occurring every single day. As you can imagine, quality of life, comfort, dignity for the patient is of foremost importance. There’s also the very real impact on the disease. About 40% of the time, cancer patients will go off their life-saving therapy specifically because of the side effect of diarrhea. Once you go off a particular targeted therapy, you’re done with that one. You have to move to another.

Now you’re really getting the attention of the healthcare provider. There’s also data that has been published, and these are third-party publications, that indicate that it costs about three times as much to take care of a cancer patient who’s managing diarrhea, because they’re ending up having to go in the hospital, they’re ending up having to go into rehydration, all sorts of other implications. Now you’re really getting the attention of the reimbursement organizations. I’m going to shift at this point to our other rare disease orphan indications, and that’s crofelemer for intestinal failure. This is crofelemer, but this is not Mytesi. This is a completely different formulation. Mytesi is a pill that you swallow. This is a highly concentrated liquid formula, which is necessary for the situation that these patients are dealing with physiologically.

As you can imagine, with intestinal failure, if you swallow a pill, it’s going to go right through rapid transit time. It’s going to land in the toilet bowl as a pill. The different formulation, the different product is also relevant as you get to rare disease indications, different business model, high mortality, high morbidity, high expense, high family patient advocacy, and typically, the incentives for higher reimbursement. Intestinal failure, we have two programs or two disease states. One is short bowel syndrome, and one is MVID, microvillous inclusion disease. We do have orphan designation in both the U.S. and Europe for each of these diseases. What is intestinal failure and short bowel syndrome? It’s a situation where the patient doesn’t have the opportunity to absorb their nutrients of life, proteins, carbs, vitamins, et cetera.

They end up on parenteral nutrition, sometimes as much as 20 hours a day, seven days a week. In short bowel syndrome, it’s because literally there’s not enough surface area to absorb the nutrients of life. As you can imagine, a completely catastrophic situation, both medically as well as for the quality of life of the patient and the entire family. In MVID, it’s the same situation, intestinal failure. The patients are on parenteral nutrition. They survive completely on parenteral nutrition. In MVID, microvillous inclusion disease, this is a genetic disorder. Children are born, and their symptom that they show immediately is complete massive diarrhea, inability to absorb any nutrients of life. If they’re not diagnosed immediately, they typically die right away.

If they don’t, and they’re diagnosed, and they’re put on parenteral nutrition, they will typically die in their early teens because of infections, complications from living on parenteral nutrition. What’s interesting is these patients have a fully intact gut. It’s just simply not functioning. It has the same treatment as short bowel syndrome, but a different gut situation. The importance of that is short bowel syndrome does have an approach that works for some patients. It’s not standard of care, but it’s essentially a growth hormone approach where you try to grow the gut a bit to increase the opportunity for some natural absorption of nutrients. You can reduce parenteral nutrition by 10% to 15%. There have been products that have been approved.

As I said, it’s not standard of care, but it has defined a regulatory endpoint, which is the reduction of parenteral nutrition, total parenteral support, by about 10% to 15%. That is not something that’s even possible in an MVID patient because their gut is completely intact. There’s no growth hormone. There’s no growth that’s going to benefit those patients. MVID is an ultra-rare disease. There’s about 200 patients around the world. What we were able to show with crofelemer, or what one of our key opinion leaders was able to show in one of the four phase 2 trials I mentioned, this was an investigator-initiated trial. In the first two patients, one with microvillous inclusion disease (MVID) and one with short bowel syndrome, and these were pediatric patients, a reduction of total parenteral support of 27% in MVID. Unheard of, groundbreaking.

Nobody thought there was an opportunity to even reduce any need for parenteral support in an MVID patient. Again, as I mentioned, because their gut is completely non-functioning. About 12.5% at this point, this was at the end of three months of treatment in a short bowel syndrome patient. This is disease progression modifying, and with an ultra-rare disease, there is the opportunity to get approval with potentially a single-digit number of patients. We do have an upcoming meeting, this is one of the near-term upcoming catalysts with the FDA to talk specifically about that. We now have three MVID patients, five MVID patients total in a clinical trial as well as investigator-initiated trials. If we continue to see this type of groundbreaking impact, how do we expedite approval?

How do we get this product to this patient population, literally 200 patients or so around the world as quickly as possible? This is the same product for short bowel syndrome. Short bowel syndrome is a population of about 40,000 around the world, and we do have both an investigator-initiated trial going on at Cleveland Clinic and a phase 2 placebo-controlled trial going on and would then look to follow on in the next 18 to 24 months after an MVID approval or approval of the same formulation for short bowel syndrome. The data that has already come out on MVID and the pediatric patient with short bowel syndrome will be presented at the North American Pediatric Gastroenterology Meeting in Chicago. I believe it’s in November of this year. What’s very interesting is the treatment has continued in these patients.

This data was reported first at the end of three months of treatment, which was the investigator-initiated protocol. Per protocol, crofelemer was removed as treatment from these patients, and within 10 days, each patient had relapsed such that they needed to go back on crofelemer. That consistent impact on the reduction of parenteral support was again achieved and maintained. We, of course, will be providing crofelemer to patients for the rest of their lives. This continuation of treatment is what will be presented in November. The product that I mentioned, the growth hormone product for short bowel syndrome, again, not a candidate of an approach for short bowel for MVID, is reimbursed at the rate of about $500,000 a year in the U.S., a couple of hundred thousand dollars a year in Europe. It is not standard of care.

However, it does set a bar for a primary endpoint for approval and a bar for reimbursement. With that level of reimbursement, we have many, many stakeholders to take care of, including those who fund and support risk-based pharmaceutical development. What is the market impact that we’re looking at for short bowel syndrome? Third-party market research have pushed that market at about $4.5 billion. That tells you that it’s blockbuster, not only for the impact that it’s having on patients’ lives and the entire caretaking community, but those who are investing in supporting risk-based drug development. What are we looking for? The manifestation of these inflection points and these catalysts right now, business development conversations, partners to help access the development that we have done to date with non-dilutive dollars and continue to fund and share commercially as we go forward.

In the cancer therapy-related area, to try to look at an analogous situation, chemotherapy-induced nausea and vomiting is a market that is about a $4 billion market at this point, and easily 50% of that market is based on generics. Those are products that are typically taken for the first three days or so in cytotoxic chemotherapy, which might last anywhere from 6 to 18 months. We are talking about a population that is taking targeted therapy every single day. Curative situation, nine months, in some cases, three to five years now is recommended in a curative situation, and for a metastatic situation for the rest of their life. Wonderfully, metastatic patients are now living 10, 15, 20 years with cancer as a chronic situation to be managed and to be managed with an important quality of life.

I just want to talk a little bit about the paradigm-shifting mechanism of action of crofelemer, which explains why there are so many different disease states that it can benefit and it can support. What’s important is what it does do and what it doesn’t do. What crofelemer does do is it normalizes, which is a verb that’s actually in the product label. It normalizes gut flow. It normalizes gut function, regardless of what the particular disease state is. What it doesn’t do is it doesn’t get systemically absorbed. It acts locally in the gut, and that is a big part of the explanation of why safety is such an important hallmark and feature of this product. You have no drug-drug interaction. You have no first pass effect causing a problem later on.

Very, very important as we get into complicated patients where you don’t want to interfere with their life-saving therapy. It’s also not an opioid. When we think about antidiarrheals like loperamide or Imodium, these are weak opioids, and they work by the mechanism of constipation. You can’t stay constipated chronically. In fact, these agents are labeled or not labeled to be utilized more than eight days, and they cause loopiness and, as you can imagine, all the other risks associated with an opioid. Once again, the safety of crofelemer is a huge, huge hallmark with thousands of patients in published clinical trials, and even more since the product has been in the market. We’ve never had a serious related drug adverse event.

As we’re running out of time, the last thing I will talk about is crofelemer is approved for chemotherapy-induced diarrhea in dogs by the Center for Veterinary Medicine of the FDA. I find it remarkable that if you’re a cancer patient in the U.S. and you are suffering from diarrhea and you are a dog, we can promote and educate you about the benefits of crofelemer. If you’re a human, not yet, but we will get there. It’s conditionally approved, and what that means is the Center for Veterinary Medicine recognized the importance of this unmet medical need, and they approved the product. You can, as I said, full promotion opportunity available with the condition that you will do a confirmatory trial within five years. We are in the midst of that confirmatory trial right now. We submitted for a grant for that type of situation last year.

The grant got held up when the administration changed. It wasn’t clear if that money was still going to become available, and somehow somebody shook the right tree, and we just got notification of it very recently, the notice of the award of $250,000. Since time has marched on and we’ve already started this trial, we’ll have to see if there’s an opportunity for us to actually be able to access those funds. An interesting discontinuity in the timing of that grant. The last thing that I will say is our sales of Mytesi, the value of being out there commercially, even in a relatively small market, has been huge because of the learning of having your first product on the market, patient access programs. It’s complicated to commercialize and get reimbursement in the U.S.

We worked out all those kinks in the HIV marketplace, and we’re growing about 5% a year, and these are sales primarily driven by Mytesi. We have a lot, a lot of really meaty news coming up, continued catalysts, and those are all for the purpose now. The priority is the support of bringing in non-dilutive dollars from the programs that we are serving up to potential corporate partners, highly, highly de-risk. I will just leave sitting up there our investment highlights at this point and turn it back to you, Roger.

Roger Weiss, Vice President, Lithium Partners: A couple of questions about your recent key announcements. How would receipt of orphan drug designation from the FDA for crofelemer for the treatment of diarrhea in patients that have breast cancer that has metastasized into the brain support the company’s development plans?

Lisa Conte, CEO, Jaguar Health: Oh, thank you for that question, because most of our business development discussions have been with companies that are focused on rare diseases and orphan indications. It’s such a powerful target and force in the pharmaceutical industry broadly now, either companies that are exclusively focused on orphan indications or bigger companies that have that as a major program. When we moved to metastatic breast cancer for a first indication that we’re looking for in the cancer area as an orphan indication, it brought the cancer indication into those discussions with companies that we were already in discussions with who were very interested and informed about our intestinal failure program. This is a much bigger indication.

It’s made those potential deals with a greater comprehensive approach to all the activities going on to the company and much larger deals, which will have a greater impact, hopefully financially, in the support of Jaguar Health going forward.

Roger Weiss, Vice President, Lithium Partners: Got it. That’s very helpful. I also wanted to just follow up. I saw a release about a financial award notice from the FDA’s Center for Veterinary Medicine for chemotherapy-induced diarrhea in dogs. How should we think about the cancer indication for crofelemer in dogs and people, and how are they related?

Lisa Conte, CEO, Jaguar Health: We love Canalevia CA1, and people love their dogs. There’s really, really the impact on quality of life and comfort of the patient seems to be more important in the dog market than sometimes it is recognized in the people market. The learning that we’ve done there is huge because, first of all, the mechanism is the same. The gut of a dog looks just like the gut of a human. You almost can’t tell the difference if you’re just looking at a picture of the gut. The impact on, for example, about 40% of the time, a dog will go off their chemotherapy specifically because of the side effect of diarrhea. Remarkably analogous to the human market.

One of the things that we saw that sort of may foreshadow the commercialization of Mytesi crofelemer into the human cancer market, should we be successful in getting there, is that if you remember that graph I showed of the diarrhea side effects of the different chemo agents, the manufacturers of those agents are almost marketing or assisting in the marketing and the promotion and the education of crofelemer. What we’ve seen in the doggy market, those manufacturers want the dog to stay on the anti-cancer medication. If they’re going off because of diarrhea, that patient is being impacted, and the company is losing sales of their cancer agent. That sort of foreshadows what we may, in fact, see on the human side. That information has been very helpful and impactful in some of our business development conversations on the human side as well.

Roger Weiss, Vice President, Lithium Partners: Got it. I see that we are out of time. Firstly, thank you again, Lisa. Really appreciate this. Also, thank you to everyone who’s out there watching us. If you have any questions or would like to schedule a meeting with Jaguar Health, please send an email to us at one-on-one, which is the number one, little X, and the number one again at lithiumpartners.com. If you’d like to learn more about Lithium Partners, you can visit our website at lithiumpartners.com or follow us on LinkedIn to stay connected about future events. We hope you enjoy the rest of the conference and have a great day.

Lisa Conte, CEO, Jaguar Health: Thank you.

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