Jaguar Health at Emerging Growth Conference: Strategic Path to Growth

On Thursday, 25 September 2025, Jaguar Health (NASDAQ:JAGX) participated in the Emerging Growth Conference 2025, presenting both opportunities and challenges in its strategic roadmap. The company is leveraging its unique position with the FDA-approved crofelemer to expand its market reach and secure nondilutive funding, while facing the task of navigating regulatory pathways for new drug indications.

Key Takeaways

• Jaguar Health is focusing on expanding Mytesi’s indication to include cancer therapy-related diarrhea, particularly in metastatic breast cancer.
• The company is actively seeking corporate partnerships to secure nondilutive funding.
• A $250,000 grant was received for a confirmatory trial of Canalevia for chemotherapy-induced diarrhea in dogs.
• Jaguar Health has filed for orphan drug designation for metastatic breast cancer and expects feedback within four to six weeks.
• The company plans to initiate additional treatment trials to expedite drug approval processes.

Financial Results

• Jaguar Health is pursuing business development deals to secure nondilutive funding.
• The company aims to leverage its derisked programs to attract potential partners, particularly in the rare disease space.

Operational Updates

• Filed for orphan drug designation with the FDA for metastatic breast cancer.
• Ongoing Phase 2 studies focus on intestinal failure.
• A confirmatory trial for Canalevia, supported by a grant, is underway to ensure market continuity for chemotherapy-induced diarrhea in dogs.

Future Outlook

• Jaguar Health plans to expand Mytesi’s indication to metastatic breast cancer patients by 2026-2027.
• Additional treatment trials for metastatic breast cancer are in the planning stages.
• Discussions are ongoing to expand Canalevia’s indication to general diarrhea in dogs.
• The company anticipates securing business development deals to bring in nondilutive dollars.

Q&A Highlights

• The strategy focuses on orphan drug designations to enhance corporate partnership discussions.
• Feedback on the orphan drug designation filing is expected within the next four to six weeks.
• The importance of orphan designations is emphasized, as they strengthen partnership discussions and align with industry trends.

Readers are encouraged to refer to the full transcript for a detailed account of the conference call.

Full transcript - Emerging Growth Conference 2025:

Operator: And welcome back, everyone. We have an update from Jaguar Health trades on the Nasdaq under the symbol j a g x. It’s a commercial stage pharmaceutical company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. So happy to welcome back founder, CEO, president, and director, Lisa Conte. Welcome back, Lisa.

We’re excited for your update today.

Lisa Conte, CEO, President, and Director, Jaguar Health: Oh, thanks so much, and I really appreciate this opportunity to do the updates because this is the season for Jaguar of Catalyst. So we’re gonna be reminding everybody of our recent Catalyst, and then there’s some very recent Catalyst that literally have happened in the past two days. And what that means for the inflection point for the company and our ultimate manifestation of what we’re looking for from this, which is business development deals bring in nondilutive dollars and and help fund the cash needs of the company as we move towards profitability. So once again, we are a public company. Reminder, our key asset is crofelemer, as you mentioned, comes from a plant.

It is plant based, organic, sustainably harvested, all that sort of stuff, and it’s an FDA approved drug. The key feature to remember as we are going through our business development conversations is that it’s the only oral drug approved by the FDA under botanical guidance. And under botanical guidance, there is no pathway to a generic. And so we essentially have exclusivity to infinity and beyond, even though we have a very robust patent strategy, 156 patents issued and more filed all the time. So really, really powerful in determining the value to a potential corporate partner when you’re not facing that patent cliff.

Crofelmer is approved currently under the trade name Mytesi, and that is for the relatively small specialty indication of HIV related diarrhea, which was fast tracked, priority reviewed by the FDA. That’s why it became our first indication. We’ll have a full pipeline, but the key opportunities that we are working on late stage now with the near term catalysts are cancer therapy related diarrhea for the Mytesi formulation and intestinal failure associated with the rare disease of short bowel syndrome and the ultra rare disease of MVID, which is prophyllumar, but a completely different formulation, a different product and a whole different businesspricing reimbursement value need in the orphan drug space. So recent catalysts, we’ve talked about we have four phase two studies going on in the intestinal failure area. Two, our investigator initiated, and we’ve put out some really powerful data there, which is going to be presented at this North American Pediatric Gastroenterology Conference in Chicago in September, and I can give you a flavor for how important that data is.

And we do have an FDA meeting coming up where we’re going to talk about pathways to expedite the approval for these rare diseases. And on the cancer area, we already had our FDA meeting for the same purpose. What are the different pathways we could take to expedite the approval of Mytesi to expand the indication from the current indication of HIV to breast cancer patients prophylactically and treatment wise for those who are on targeted therapies? Let me talk about that first. That was an announcement that we made this week.

We have now filed for orphan drug designation with metastatic breast cancer. As a reminder, we did a phase three trial, a first pivotal trial, prophylaxis of all solid tumor types on targeted therapy with or without cytotoxic chemotherapy, prophylactic, a big broad, bold study embracing the whole community. Where we saw statistical significance was in the breast cancer patients. It was that data package that we took to the FDA led by patient advocates who had received prescriptions off label and said, Hey, drug’s safe. It’s manufactured, obviously, according to GMP.

It’s on the market. We’ve seen the data that’s been published on breast cancer patients. We have some patients who have received prescriptions off label. The company had nothing to do with that. How do we get this product approved and in a reimbursable situation for as many breast cancer patients as possible?

What came out of that meeting is a strategy to focus on an orphan population of metastatic breast cancer patients because of the greater flexibility in regulatory and all the additional assistance that comes from a regulatory process for an orphan indication. Metastatic breast cancer patients is about one hundred and fifty thousand patients under the two hundred thousand for an orphan population. But even within metastatic breast cancer, Breast cancer that has metastasized to the brain already has been recognized by the FDA as a separate disease that has received orphan designation in other scenarios. So that’s where we filed the application. To be clear, the additional trial that we will do to expedite the approval for this indication will be broader within the metastatic breast cancer patient population and will be a treatment trial.

So we’ll have the prophylactic trial, which will be supportive of a supplemental NDA, a treatment trial, and hopefully by the 2026, 2027, have the package to support the expansion of the indication of a product that’s already approved, already been on the market with a chronic safe indication from HIV patients to metastatic breast cancer patients. And then we will continue with the cancer population thereafter. The second very recent announcement was actually just came out today, also in the cancer area, however, in the animal health area. So we do have a product approved, Crofelimer, for chemotherapy induced diarrhea in dogs. It’s a conditional approval.

A conditional approval under something called mums is sort of akin to an orphan indication in humans. So based on the dramatic need, the Center of Veterinary Medicine under the FDA gives an approval so we can promote all the advantages that you have with an FDA approved product with the condition that you do a confirmatory trial within a five year period of time. And under MUM’s, there is an opportunity to apply for a grant. And we got notification just this week that we have been the recipient of the grant. It’s about $250,000 that can be utilized towards that confirmatory trial.

There are some terms and conditions. We just got it. We’re reading through those. We haven’t accepted the award yet. However, the key thing is recognizing the importance of this conditional approval and turning it into a full approval so we maintain continuity in the access of these animals to the product.

While at the same time, we are in discussions with corporate partners to expand the indication to general diarrhea, all sorts of acute diarrhea, potentially acute and chronic diarrheas in dogs for the same product, Canalevia. But again, this trial where we have received notice of the award is to provide the continuity of the product on the market for the chemotherapy induced diarrhea indication. So with that, those are the updates. I’m just going to quickly show that there are a lot of catalysts. There are a lot of highlights in this company.

More to come. Ultimately, what we’re looking to do with these key inflection points is bring in corporate partners. We are at that point where these programs have been very dramatically derisked and have commercialization opportunities with insights and bring in those nondilutive dollars, which is so important in this funding environment.

Operator: Thank you, Lisa. Yes. Congratulations on this. This is big news. Talk a little bit.

We don’t have that much time, but talk a little bit about the receipt of the orphan drug designation from the FDA and how it will support the company’s development plans.

Lisa Conte, CEO, President, and Director, Jaguar Health: What was really fascinating about the opportunity to move to an orphan indication initially with cancer. Remember, there’s a whole world of cancers out there that are dealing with targeted therapies and are managing diarrhea. But an initial opportunity for flexibility with the regulatory pathway. Most of the companies that we are talking to for corporate partnerships have adopted a very strong rare disease strategy. And so it has moved those conversations or broadened those conversations from just the IF program, which is very important, to include the cancer program as well.

So it has really strengthened and given greater breadth and therefore depth of dollars to the types of corporate partner discussions that we have going on since orphan populations are just so important right now in drug development and the industry as a whole.

Operator: Yes. And Rowan wants to know what’s next on the ODD filing and when are

Lisa Conte, CEO, President, and Director, Jaguar Health: you expecting comments? The comments usually come we just filed. So there there is a particular time frame that they get back to you and you have two shots to go back. We do have orphan drug designation for short bowel syndrome, for MVID, and for cholera. I think in each case, there was a set of questions that we went back for the second time.

So we would fully expect that to happen probably in the next four to six weeks.

Operator: Perfect. Well, thank you, Lisa, for this update. Really enjoy following along with this important journey you’re on.

Lisa Conte, CEO, President, and Director, Jaguar Health: Thanks so much. Appreciate it, too. Look forward to the next one.

Operator: Thank you. See you soon. All right, everyone. We’ll be right back.

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