Jaguar Health at Emerging Growth Virtual Conference: Strategic Catalysts Ahead

On Thursday, 27 March 2025, Jaguar Health Inc. (NASDAQ: JAGX) participated in the Emerging Growth Virtual Conference, presenting a strategic overview focused on upcoming catalysts for their programs. Led by CEO Lisa Conte, the discussion highlighted potential regulatory advancements and partnerships, while also acknowledging the challenges of the pharmaceutical development landscape.

Key Takeaways

• Jaguar Health is advancing two major programs targeting rare diseases and cancer-related diarrhea.
• The company anticipates proof-of-concept study results within a month, which could lead to regulatory advantages in the US and Europe.
• A bridge financing was recently closed to support upcoming catalysts and potential value recognition.
• The company is actively seeking partnerships for co-promotion and global collaborations.

Financial Results

• The cash position will be disclosed in the upcoming K filing and earnings call.
• A bridge financing was secured with participation from executives and long-term investors, aimed at supporting near-term catalysts and achieving value recognition.

Operational Updates

• Rare Disease Program (MVID & SBS):

- Two placebo-controlled Phase 3 trials are ongoing globally.

- Initial results from two proof-of-concept studies are expected in about a month.

- Data will be presented at the April pediatric gastroenterology conference.

- The company is targeting PRIME designation in Europe and breakthrough designation in the US.

• MITESI (Crotalmer) Program:

- Already FDA-approved for HIV-related diarrhea.

- Phase 3 trial for prophylaxis of diarrhea in solid tumor patients showed significant data in breast cancer patients.

- A Type C meeting with the FDA is scheduled in Q2 to discuss a supplemental NDA for breast cancer patients.

• Cantilevia (Cofelamer):

- Approved for chemotherapy-induced diarrhea in dogs.

- Jaguar Health is seeking partnerships to expand its use to general diarrhea in all companion animals.

Future Outlook

• Business Development:

- The company is pursuing partnerships for co-promotion in the US and global licenses/collaborations.

• Regulatory Goals:

- Jaguar Health aims to secure regulatory approval and reimbursement for MITESI as a prophylaxis for diarrhea in breast cancer patients.

- The company is seeking early patient access and reimbursement through the PRIME designation in Europe and breakthrough designation in the US.

Q&A Highlights

• PRIME Program:

- The program aims to expedite approval and access for treatments in areas with unmet needs.

- Benefits include reduced regulatory costs and early patient access in select European countries.

• Connection with Sheikh Khalifa Medical City Hospital:

- Established eight years ago due to the high prevalence of genetic disorders in the Middle East.

- Dr. McDaddy is the principal investigator for the related trial.

• FDA Meeting Best-Case Scenario:

- Securing the opportunity to file a supplemental NDA for MITESI for prophylaxis of diarrhea in breast cancer patients.

Readers are encouraged to refer to the full transcript for a detailed understanding of Jaguar Health’s strategic initiatives.

Full transcript - Emerging Growth Virtual Conference:

Anna Berry, Host, Emerging Growth Conference: Welcome back, everyone. We have an update from Jaguar Health Inc, trades on the Nasdaq under the symbol JAGX. 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. Happy to welcome back CEO, president, and director, and founder, Lisa Conte. Welcome back to the conference, Lisa.

We look forward to hearing your update.

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: Thanks, and I appreciate the opportunity to do that today. And, Jaguar and our wholly owned subsidiary, NAPO, so sometimes I use those words interchangeably. We are a publicly traded company. So this is a really important time in the company. We just passed, believe it or not, our thirty sixth anniversary.

And, you know, pharmaceutical development does not happen overnight, but we just seem to be at a time where we have a convergence of catalysts, really important catalysts. Our two major programs have five clinical regulatory near term catalysts. And what’s the manifestation of that? What we expect that to lead to is major collaborations, business development deals, the opportunity to bring in non dilutive dollars for the important work that we’ve done for all the stakeholders, patients first and foremost. So we also just completed a reverse split.

We are now trading at a couple of dollars 5 dollars plus $5.5 I think today. And, you know, that’s always tough. And the classic definition of insanity doing something same thing over and expecting something different. But what’s equally crazy is to think about doing things different and think things that are not going to change. And that’s what the catalysts are giving us the opportunity to do.

So first and foremost, I’m going to talk about our rare disease program. This is intestinal failure, an intestinal failure associated with, an ultra rare disease called MVID and short bowel syndrome. These are situations where children, their intestine is failing, So they are not able to absorb the nutrients of life and they’re on parenteral nutrition, IV nutrition, up to twenty hours a day, seven days a week. Absolutely catastrophic for these patients. We have two placebo controlled blinded phase three clinical trials going on globally, which you typically do with a rare disease.

And we have two proof of concept studies that have started in particular with children with MVID and SBS intestinal failure. We should have the first two proof of concept results in in about a month. They they started several weeks ago, so in about a month. What’s the importance of with an ultra rare disease where there is absolutely no treatment whatsoever with published proof of concept data, we have the opportunity to potentially through PRIME in the EMA, which is the FDA of Europe, breakthrough designation in The United States to potentially have approval and early patient access with literally a single digit number of patients because there’s absolutely nothing out there for these children. So those are the catalysts coming up in the rare disease area.

There’s a conference, a major pediatric gastroenterology conference that is led by the principal investigator in our investigator initiated trial who is treating these patients, with the proof of concept data and that is the April. So hopefully, data will be presented at that conference. Our second major program is MITESI, our FDA approved product for AIDS related diarrhea. And this is the same active ingredient, crapelymer, but in a completely different formulation, a different product than the rare disease product, as I mentioned, already approved. We completed a phase three clinical trial last year for prophylaxis of diarrhea in all targeted in all patients with solid tumors on targeted therapy with or without cytotoxic chemotherapy.

We did not hit the primary endpoint for everybody. However, with breast cancer patients, we have statistically significant data, in which was presented at San Antonio Breast Cancer Conference. And we just announced today that we have further data submitted to another conference, MASC, which is a supportive care conference and the FDA has granted us a Type C face to face meeting in the second quarter. The goal of that meeting is to clarify the opportunity to gain approval and therefore reimbursement for my TESI, the product that’s already approved with a supplemental NDA for prophylaxis with breast cancer patients. And we do have a very strong patient advocacy program that we’ve worked on for years, absolutely fabulous men and women.

And the breast cancer patient advocates will be a part of our regulatory, approach as well. Finally, the manifestation of each of these programs separately are to look for partners. What we like to do is have, at the very least, co promotion in The United States, licenses and partners collaborations around the world. And we do have another program, Cantilevia, which is Cofelamer approved for chemotherapy induced diarrhea in dogs, which we’d like to expand to general diarrhea in all companion animals and seeking a partnership in that area as well. So, in conclusion, the targeted therapy agents which cause rates of diarrhea, which I zipped by very quickly, very, very high rates from there’s 70 different targeted therapies out there, all that work and cause diarrhea by a mechanism that we normalize.

If you are a dog with cancer and diarrhea in The United States, you can receive a prescription for Crofelmer. If you’re a human, not yet. But we’re getting there. We do have the data. So let me stop there for a moment and see if there’s any questions, Anna.

Anna Berry, Host, Emerging Growth Conference: Wonderful. Thank you, Lisa. We do have a few questions. What is PRIME, the breakthrough therapies program, and early patient access?

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: Thank you for this question, Yara. That’s and so pleased that we are making a priority or certainly an equal approach with the regulatory agencies in Europe given a little bit of disruption going on here in The United States right now. So, PRIME is a priority, medicines. And when you have something like MVID or intestinal failure where there’s no treatment out there at all and a very small patient population, the regulatory agency wants to minimize the time that patients have to spend in clinical trials when there is proof of concept out there. So, when we have a couple of patients and if we’re able to show modification in the reduction of the need of parenteral nutrition, that’s that’s the the brass ring here.

You can meet with Prime, which we’ve already done. You can apply for Prime designation and then you have, less regulatory costs. You have advocates, repertoires who are on your side to help navigate through and as quickly as possible, get the product full approval in the 37 different European countries, and and have it fully reimbursed. Parallel process to that is I’m sorry, 27 European countries is early patient access, which is country by country, where, again, it’s reimbursed early patient access to the products. Usually, Italy, The UK, France, and Germany is an opportunity.

Breakthrough designation is sort of the the sister here in The United States with the FDA to the prime designation, although you don’t get quite as much assistance as you do in Europe. In all cases, because it’s ultra rare, MVID, we’re talking about literally a single digit number of patients, and we have two, possibly three, that will be presented in the next two months or so. So really exciting times.

Anna Berry, Host, Emerging Growth Conference: Great. Congrats. And talk a little bit how you got connected with Sheikh Khalifa Medical City Hospital in Abu Dhabi and doctor Mick Mickdaddy.

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: Doctor McDaddy. Yeah. He’s the principal investigator. So that conference that I mentioned, that is April 24. The Pedal lead conference, that’s his conference.

He’s head of the Pediatric Gastroenterology Society in the MENA region. We met and started these plans eight years ago. And how that happened, I was actually in The Middle East. I was on my way to Saudi Arabia, to meet with some potential investors. These were government funds.

And I said, what, you know, what are you looking for? They said, anything that treats, prevents, diagnosis a genetic disorder because of the consanguineous marriages is something that gets a priority for us to look for. I happen to be in Abu Dhabi because my daughter was starting fate. I met doctor McDaddy, a pediatric gastroenterologist in The United States might deal with one MVID patient in their entire career with their colleagues. Doctor.

McDaddy is treating probably 70 different intestinal failure children. So, that started the program and then you meet with KOLs and regulatory agencies and patient advocacy organizations and trial design and endpoint definition. And here, we have organizations and trial design and endpoint definition. And here we go. Now it’s showtime, the the convergence of these key catalysts that will be happening literally in the next month.

Anna Berry, Host, Emerging Growth Conference: Great. Great. Marcel asks, what’s the best case scenario for your FDA meeting coming up, and what will the next step be?

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: The the FDA meeting, so now we’re shifting to MiTESE. So that’s the the pill formulation, the product that’s already approved for HIV related diarrhea. What we are looking for is the opportunity to file a supplemental NDA. So for the product that’s already on the market for prophylaxis of diarrhea and breast cancer patients on targeted therapy regardless of whether on cytotoxic chemotherapy. That’s the statistically significant responder analysis that was presented at San Antonio.

The responder analysis is the analysis that got the product approved for HIV related diarrhea. It was about sixty five percent of the patients in the, on target trial, the cancer trial. And we think that’s why we see the significance in breast cancer patients. Whereas for the whole trial, you had 10 different tumor types, 24 different targeted agents. You need to give cancer patients what they need.

A lot of them, if not all of them, end up on an opioid at some point for pain. Opioids cause constipation. We’re doing a diarrhea trial. So we’re very energized by the results that we’ve been able to pull out in breast cancer patients.

Anna Berry, Host, Emerging Growth Conference: Wonderful. And last question is if you can discuss briefly your cash position and what’s the runway?

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: So we are filing our K and we’ll have our earnings call on Monday so everybody will see our cash position, from the end of the quarter. I shouldn’t announce that right at this moment. However, what I can say is we did just close, we announced yesterday, a bridge financing, which was participation from myself, all the chief executives of the company, multiple members of the board as well as some of our key long term investors, bridge bridge to what? Not appear. A bridge and obviously to the catalyst that we have coming up and hope to get some value recognition in the company.

Anna Berry, Host, Emerging Growth Conference: Wonderful. Well, Lisa, thank you for this update, and good luck with all of the upcoming events. And please keep us posted and come back and give us some more updates like this.

Lisa Conte, CEO, President, and Director and Founder, Jaguar Health Inc: Absolutely. Thank you. Thank you for the questions.

Anna Berry, Host, Emerging Growth Conference: Alright, everyone. Thank you so much. It’s been a great conference today. In just a moment, you’ll be redirected to the registration page to reserve your spot for our next conference. On behalf of all of us, thank you for all those who attended and watching.

And remember, complete replay of this conference separated by company will be on our YouTube channel, so please subscribe there and follow us on x at emerging growth c. I’m Anna Berry. On behalf of myself and our entire team, thanks for watching, and we’ll see you next month.

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