Welcome back, everyone. We have an update from Jaguar Health. 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, Director, and Founder Lisa Conte. Welcome back to the conference, Lisa. We look forward to hearing your update.
Thanks, and I appreciate the opportunity to do that today. Jaguar and our wholly owned subsidiary, Napo, so sometimes I use those words interchangeably. We are a publicly traded company. This is a really important time in the company. We just passed, believe it or not, our 36th anniversary. 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. 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. We also just completed a reverse split.
We are now trading at a couple of dollars, $5+ , $5.50, I think, today. You know, that's always tough. The classic definition of insanity: doing something, same thing over, and expecting something different. What's equally crazy is to think about doing things different and think things that are not going to change. That's what the catalysts are giving us the opportunity to do. 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 20 hours a day, seven days a week. Absolutely catastrophic for these patients.
We have two placebo-controlled, blinded phase III clinical trials going on globally, what you typically do with a rare disease. 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 about a month. 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. 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 end of April. Hopefully, data will be presented at that conference. Our second major program is MyTESY, our FDA-approved product for AIDS-related diarrhea. This is the same active ingredient, crofelemer, 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 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, which was presented at San Antonio Breast Cancer Conference.
We just announced today that we have further data submitted to another conference, MASC, which is the 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 MyTESY, the product that's already approved with a supplemental NDA for prophylaxis with breast cancer patients. We do have a very strong patient advocacy program that we've worked on for years. Absolutely fabulous, men and women. The breast cancer patient advocates will be a part of our regulatory approach as well. Finally, the manifestation of each of these programs separately is 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.
We do have another program, Canalevia, which is crofelemer 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. In conclusion, the targeted therapy agents, which cause rates of diarrhea, which I zipped by very quickly, very, very high rates from there are 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 crofelemer. If you're a human, not yet, but we're getting there. We do have the data. Let me stop there for a moment and see if there's any questions, Anna.
Wonderful. Thank you, Lisa. We do have a few questions. What is PRIME, the breakthrough therapies program, and early patient access?
Thank you for this question, Yara. I am 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. PRIME is priority medicines. When you have something like MVID or intestinal failure where there is 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. When we have a couple of patients and if we are able to show modification in the reduction of the need of parenteral nutrition, that is the brass ring here. You can meet with PRIME, which we have 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 27 different European countries and have it fully reimbursed. Parallel process to that is early patient access, which is country by country, where again, it's reimbursed early patient access to the products. Usually, Italy, the U.K., France, and Germany is an opportunity. Breakthrough designation is sort of 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.
Great. Congrats. Talk a little bit how you got connected with Sheikh Khalifa Medical City Hospital in Abu Dhabi and Dr. Miqdady.
Dr. Miqdady, yeah, he's the principal investigator. That conference that I mentioned that is April 24, the Elite PED‑GI 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. 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. I said, "What are you looking for?" They said, "Anything that treats, prevents, diagnoses a genetic disorder because the consanguineous marriages is something that gets a priority for us to look for." I happened to be in Abu Dhabi because my daughter was starting at NYU Abu Dhabi right next to where this conference was going on. It was fate. I met Dr. Miqdady, a Pediatric Gastroenterologist in the United States might deal with one MVID patient in their entire career with their colleagues.
Dr. Miqdady is treating probably 70 different intestinal failure children. That started the program, and you meet with KOLs and regulatory agencies and patient advocacy organizations and trial design and endpoint definition. Here we go. Now it's showtime, the convergence of these key catalysts that will be happening literally in the next month.
Great. Great. Marcella asks, "What's the best-case scenario for your FDA meeting coming up, and what will the next step be?
The FDA meetings are now, we're shifting to MyTESY. That's 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, for the product that's already on the market for prophylaxis of diarrhea in breast cancer patients on targeted therapy, regardless of whether they're 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 65% of the patients in the on-target trial, the cancer trial. 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. We are very energized by the results that we've been able to pull out in breast cancer patients.
Wonderful. Last question is, if you can discuss briefly your cash position and what's the runway?
We are filing our K, and we'll have our earnings call on Monday. 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 a pier, a bridge, and obviously to the catalysts that we have coming up and hope to get some value recognition in the company.
Wonderful. Lisa, thank you for this update, and good luck with all of the upcoming events. Please keep us posted and come back and give us some more updates like this.
Absolutely. Thank you. Thank you for the questions.
All right, 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. Remember, a complete replay of this conference separated by company will be on our YouTube channel. Please subscribe there and follow us on X @EmergingGrowthC. I'm Anna Berry on behalf of myself and our entire team. Thanks for watching, and we'll see you next month.