JAGX

Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations, and projections about future events. While management believes that the assumptions, expectations, and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements.

The company's actual results may differ materially from those discussed during the webcast for a variety of reasons, including those described in the Forward-Looking Statements and Risk Factors sections of the company's Form 10-K for the year 2025, which was filed with the SEC on April 7th, 2026, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses and operates the business.

These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours.

Hello. Thanks very much. Hello, and thank you for joining our Investor webcast this morning. I hope you all had a great holiday weekend. My name is Lisa Conte. I'm the Founder, President, and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals, and I am the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably to refer to our company. After our speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the first quarter of 2026. The theme of today's webcast is transformation and sharp strategic focus.

I'm going to preempt Carol, as we're pleased to report that the company's net revenue increased 816% in the first quarter of 2026 versus the first quarter of 2025 and increased 527% in the first quarter of 2026 versus the fourth quarter of 2025.

Buoyed by the transformative event of the U.S. out-license agreement we executed this past January 2026, with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer for adults living with HIV, AIDS, and experiencing diarrhea. Included in the license was Canalevia-CA1, our conditionally approved formulation of crofelemer for dogs. We made the strategic decision to out-license Mytesi and Canalevia-CA1 to Future Pak, first, because they had recently acquired Theratechnologies, an HIV-focused commercial company with more than four times the commercial effort of Jaguar in the United States. Secondly, to fulfill our strategic plan to bring in meaningful non-dilutive dollars to fund our sharp development focus on our pivotal stage program for our novel proprietary powder for oral solution formulation of crofelemer. A different formulation than the Mytesi tablets. Powder for oral solution formulation of crofelemer for rare intestinal failure indications.

Our strategy then continues with the goal of identifying a development and commercialization partner for this program as well. The near-term value driver in our intestinal failure development program is our lead target indication, pediatric microvillus inclusion disease, MVID, an ultra-rare disorder with no approved therapies. We've embarked on an ongoing clinical path toward a potential NDA new drug application submission in mid-2027. NDA new drug application submission to the FDA. Short bowel syndrome, which I'll refer to as SBS with Intestinal failure, SBS-IF, represents a larger follow-on indication using the same dosage form, different from Mytesi tabs again, the same powder for liquid dosage form and physiological mechanism as IF with MVID patients. Intestinal failure program represents a blockbuster global market opportunity in terms of addressing this catastrophic unmet medical need in patients with a lethal natural history.

Blockbuster in terms of the beneficial impact to morbidity, mortality, and the cost to the healthcare systems, and blockbuster in terms of the financial return opportunity for all stakeholders, and especially important to a potential corporate partner. As an example, the global market for Short Bowel Syndrome, including Short Bowel Syndrome with Intestinal failure, is estimated to reach approximately $8 billion by 2033, according to a third-party market research study, and a third-party estimate of the value of the global MVID marketplace puts it over $1 billion. I'd like to take a moment to describe the catastrophic impact intestinal failure to patients and their caregiving community, their healthcare providers, doctors, nurses, nutritionists, family members, and others involved in that caretaking.

Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes, and nutrients through intravenous administration, which consists of total parenteral nutrition, TPN, with supplemental intravenous fluids, which altogether constitute parenteral support, PS, parenteral support. Many intestinal failure patients require parenteral support up to seven days a week and sometimes for 20 hours a day or more. Obviously, catastrophic and no quality of life. While crucial for survival for intestinal failure patients, parenteral support is associated with significant toxicities to patients, often causing serious health problems, including liver and kidney function problems, metabolic complications, infections, cognitive impairment, and in children, significant growth impairment. These symptoms often become life-threatening. The cost of PS, parenteral support, is estimated at about $500,000 per year in the United States, and the cost to the healthcare system with the inevitable complications can top $1 million per year per patient.

The key benefit to IF patients on parenteral support and the key endpoint in clinical development is the possibility to reduce PS by even 10%-15%. The value, for example, would allow the patient to receive most of their PS at night while sleeping while preserving some quality of life during waking hours. As a further example, a child might then be able to attend school without the need to be attached to IV for parenteral support. In November 2025, last year, groundbreaking initial results of the ongoing and independent proof-of-concept study of crofelemer in pediatric patients in the UAE, United Arab Emirates, intestinal failure due to MVID and SBS-IF were presented at NASPGHAN. That's the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. That's a mouthful, NASPGHAN, the Annual Meeting, and it was presented by the study's primary investigator.

The initial results demonstrate disease progression modification with crofelemer through reduction of parenteral support in intestinal failure patients that ranged from 12%-37%. Specifically, in the two pediatric IF patients who completed treatment, the results showed crofelemer reduced parenteral support between 12.5% and 15.6%. For the MVID patient, again, where there's no alternative treatment, parenteral support needs were reduced by up to 37%. It's worth saying again, 37%, a remarkable result. Multiple patients intestinal failure due to either MVID or SBS who are taking part in the trial in the U.A.E. have now been treated for more than one year, and longer-term data will be presented at the annual meeting of ESPGHAN, another mouthful, the European, not North American, European Society for Pediatric Gastroenterology, Hepatology and Nutrition, next month in June 2026.

An additional MVID infant patient is being treated with oral crofelemer under an FDA-authorized expanded access program, and safety and efficacy data regarding crofelemer treatment in this infant will also be presented at the ESPGHAN conference. This is a fascinating situation where the patient, the young infant, diagnosed with MVID right after birth, was too young to enroll in our clinical trial, which I'm going to talk about in a moment. With the expanded access to crofelemer, the child is now nine months old and thriving in the 27% growth curve in what is otherwise a catastrophic diagnosis with a lethal natural history. Crofelemer has been well-tolerated and the pediatric MVID patients are gaining weight and height and demonstrating reductions in their daily and weekly needs for parenteral support.

There have been no crofelemer-related safety issues in intestinal failure patients, which is consistent with the safety profile of crofelemer as demonstrated in thousands of patients in clinical trials for other disorders and years of commercial availability of the drug as the FDA approved for HIV-related diarrhea. We expect the pediatric intestinal failure patients participating in these ongoing programs to be provided with crofelemer from the company for the rest of their lives. We take great pride in that. We are simultaneously conducting a pivotal randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of the liquid formulation of crofelemer in pediatric patients with intestinal failure due to MVID. This trial is fully enrolled.

In pursuit of an NDA filing, a new drug application filing, with the FDA based on patients in this trial, Napo submitted an amendment and received FDA support for a treatment-only extension phase for this study. The first MVID patient has entered the treatment-only extension phase of this trial, which is taking place at clinical sites in the U.S., Italy, and the U.A.E. We expect the rest of the enrolled patients to enter the treatment-only phase over the next two months as each participating institution provides their approval to supplement the acknowledgment from the FDA. Including the patients in the blinded trial and MVID patients in the expanded access and the investigator-initiated trials, the ones that will be presented at ESPGHAN next month, we estimate we're treating approximately 4% of the patient population, of the global patient population, of this ultra-rare disease, MVID.

We are confident and, as you can probably imagine hearing here, passionate to bring the benefit of crofelemer to approval for the benefit of all MVID patients in as expeditious a manner as possible. Drugs get approved based on a benefit-risk ratio. Clinical trials have demonstrated no risk, excellent tolerance with crofelemer, and the benefits in PS reduction, particularly compared to weight in a growing pediatric population, speak for themselves. We feel this is a powerful result, providing breakthrough adjunctive therapy to reducing PS support needs and the concomitant toxicities that come with that life-saving PS. Because of the ultra-rare nature of MVID, again, a disorder for which there are no approved treatments, and with the continuation of the benefit we are seeing, we hope to achieve breakthrough therapy designation from the FDA for crofelemer to accelerate even further the U.S. regulatory pathway to market.

We're also focused on potential EMA, European Medicines Agency, that's the equivalent of the FDA in Europe, pathways to accelerate the regulatory approval to market in all 27 EU countries as well. Breakthrough designation in the U.S. would give an approval timeline of four months. As I mentioned, our crofelemer intestinal failure programs are also enhanced by clinical proof-of-concept data in pediatric patients with intestinal failure due to short bowel syndrome, SBS. Our oral liquid formulation of crofelemer is a non-growth hormone drug candidate for use as adjunctive therapy to parenteral support through its unique first-in-class physiological mechanism of action of reducing liquid stool output, thus reducing parenteral support needs. Crofelemer is a locally acting intestinal chloride ion channel modulator that reduces intestinal chloride-driven fluid accumulation. Think osmosis.

Intestinal fluid, chloride-driven fluid accumulation in the GI tract, resulting in reduction of electrolyte and fluid losses and concordant parenteral support reductions, a clinically relevant endpoint. In both MVID and SBS/SBS-IF, the value proposition is a reduction in parenteral support requirements in patients with no available therapies other than lifelong, life-sustaining parenteral support, which is associated with high comorbidities, often resulting in death. We have a phase II randomized, double-blind, placebo-controlled trial of the liquid formulation of crofelemer, the same formulation as MVID, ongoing in adult SBS-IF patients at various sites in Germany and Italy. SBS-IF affects a significantly larger patient population than MVID, although still an orphan indication, and it arises from congenital anomalies or surgical resection due to conditions like Crohn's disease, mesenteric ischemia, cancer, and trauma. Adult and pediatric SBS-IF patients face chronic dependence on parenteral support due to insufficient absorptive surface area in their intestines.

The U.S. SBS-IF patient population is estimated at 12,500 patients. We are targeting the new drug application filing of crofelemer for MVID in mid-2027, coincident with the expected timing of the availability of results of our phase II blinded study for adults with SBS-IF. As the same IF formulation, this plan provides a CMC stepping stone to our planned pathway for ultimate approval for Short Bowel Syndrome. Our entire IF program is the subject of business development discussions, specifically. We are interested in a partner to assist in the funding for final development and commercialization of crofelemer for MVID and SBS/IF outside the U.S. We established our ability to perform and close important non-dilutive business development deals, as we did in January this year with Future Pak.

With $16 million non-dilutive received upfront in January when the deal closed, $2 million due shortly to Jaguar upon completion of post closing conditions. We've additionally received further non-dilutive funding from the deal terms of $3 million and ongoing meaningful dollars from inventory purchase, which is purchased at a profit to Jaguar. Intestinal failure market is considered to be approximately 100 times larger than the HIV diarrhea market. Put that in perspective when you think about the size of the deals we're targeting for business development for IF.

With the clinical proof of concept data we have in hand and near-term clinical and regulatory milestones ongoing, we are confident in our ability to execute upon our business development goals and strategy in our intestinal failure program to further the opportunity to bring in meaningful non-dilutive dollars commensurate with the market size driven by a very serious unmet medical need. I'm now going to hand over the discussion to Carol for her recap of the financial highlights for the first quarter of 2026. Thank you, Carol.

Good morning, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the first quarter of 2026. Fueled by the license of U.S. commercial rights for Mytesi and Canalevia-CA1 in January 2026, the total net revenue for the company's prescription products, Mytesi, Gelclair, and Canalevia-CA1, non-prescription products, and license revenue was approximately $20.2 million in the first quarter of 2026, representing an increase of approximately 816% over the total net revenue in the first quarter of 2025, which totaled approximately $2.2 million and an increase of approximately 527% over the total net revenue in the fourth quarter of 2025, which totaled approximately $3.2 million.

The total net revenue for the company's prescription products in the first quarter of 2026 was approximately $1.2 million, of which approximately $174,000 stemmed from sales of Mytesi inventory in the first 11 days of the first quarter of 2026, with the remaining bulk of the $1.2 million net revenue stemming from sales of Mytesi inventory to Future Pak later in the first quarter of 2026. In January 2026, as Lisa stated, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1 effective from January 12, 2026, are directed to Future Pak. This decision aligns with Jaguar's strategic focus on advancing the development of its powder for oral solution formulation of crofelemer for rare disease indications related to intestinal failure in humans.

Net revenue for the company's prescription products decreased 62% compared to the fourth quarter of 2025, when total net revenue for prescription products was approximately $3.2 million. Additionally, prescription products net revenue decreased by 45% in the first quarter of 2026 compared to the same quarter of 2025, when total net revenue for prescription products amounted to approximately $2.2 million. Income from operations increased to $19.6 million from a loss of $9.4 million in the quarter ended March 31, 2025, to income of $10.2 million in the quarter ended March 31, 2026, largely from the license revenue recognized under the Future Pak agreement and decreased operating expenses. Non-GAAP recurring EBITDA for the first quarters of 2026 and 2025 were a net loss of $6.4 million and $9.7 million, respectively.

Net loss attributable to common shareholders decreased by approximately $3.4 million from a loss of $10.5 million in the quarter ended March 31, 2025, to a loss of $7.1 million in the quarter ended March 31, 2026. In addition to the loss from operations, interest expense increased by $800,000 from $56,000 for the quarter ended March 31, 2025, to approximately $700,000 in the quarter ended March 31, 2026, due to interest expenses accrued on new notes. The fair value of financial and hybrid instrument designated as fair value option or FVO decreased by $1 million from a loss of $1.3 million in the quarter ended March 31, 2025, to a loss of $300,000 in the quarter ended March 31, 2026. Primarily due to fair value adjustments in liability classified warrants and notes payable designated as FVO.

Loss on extinguishment of debt was $600,000 during the three months ended March 31, 2026, due to significant modifications that qualified for extinguishment accounting with none recorded in the same period in 2025. Well, that concludes my recap of high-level financials for the first quarter of 2026. I will now hand the discussion back to Lisa.

Thanks, Carol. As I mentioned, our intestinal failure program is expected to continue to provide clinical proof of concept milestones and is the subject of business development discussions with potential to bring in non-dilutive funds from potential licensee partners. Importantly, crofelemer's status as the first and only oral prescription drug approved by the FDA under Botanical Guidance functions as a de facto and perpetual IP shield. All members of the Jaguar, Napo, and Napo Therapeutics family remain fully energized and excited about the multiple expected near-term catalysts for crofelemer and the company, all of which we view as significant, value-enhancing, transformative, and potentially transformative for patients as well as Jaguar. This concludes our webcast for today. Thank you all for joining, and have a wonderful week.

Greetings, and welcome to Jaguar Health Investor Webcast. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on current available information and management's current assumptions, expectations, and projections about future events.

While management believes its assumptions, expectations, and projections are reasonable in the view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the Forward-Looking Statements and Risk Factor sections of the company's Form 10-K for the year 2025, which was filed with the SEC on April 7th, 2026, and its other filings with the SEC, which are available in the Investor Relations section of Jaguar's website. Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise.

Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours.

Thanks very much, Melissa, and thank you, everybody. Hello. Thank you for joining the investor webcast today. As you heard, my name's Lisa Conte. I'm the Founder, President, and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I am the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably to refer to the company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the fourth quarter of 2025 last year.

I am once again pleased to steal Carol's thunder, and I am further pleased to report that our combined net fourth quarter 2025 revenue of approximately $3.2 million for both our prescription and non-prescription products, including license revenue, increased approximately 5% versus the net Q3 2025 of approximately $3.1 million. Our strategy for 2026 is business development, and I'm pleased to add the description continued business development. Our theme is what's different now. Let me start by addressing our achievement of bringing about a transformative business platform at Jaguar. The key event was the closing of a U.S. out-license agreement with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer, Mytesi. An agreement that is fully aligned with our strategy to sharply focus our crofelemer development efforts on rare disease intestinal failure indications.

The out-license agreement also covers Canalevia-CA1 crofelemer for the treatment of chemotherapy-induced diarrhea in dogs as conditionally approved. The key transformative points of this deal are straightforward. First, there's non-dilutive dollars that provide the fuel for the development of our rare disease pipeline. The deal had $18 million up front, of which $16 million we have already received. We received when we signed the deal in January, $2 million coming based on certain conditions, and an additional $20 million in milestone payments and other future payments. These are non-dilutive dollars, and we've already received close to $4 million of additional payments above and beyond the $16 million. This is, again, non-dilutive dollars. This has been our vision. This has been our mission. This has been our objective for several years now. Jaguar continues to be the manufacturer of crofelemer, and we are selling it to Future Pak at a profit.

It now has become a profit center. We have really breakthrough data in the rare disease area, which I'm going to be talking about in a moment, and near-term development catalysts, clinical catalysts, regulatory catalysts for disease with a lethal natural history, and with endpoints that we're looking at to potentially extend life for this situation. We're in late-stage clinical development in our rare disease intestinal failure program, and that includes something called MVID, microvillus inclusion disease, which is an ultra-rare congenital diarrheal disorder, and short bowel syndrome with intestinal failure. MVID, we are targeting a New Drug Application for 2027, and that would be coincident with completing a phase II trial, a placebo-controlled trial for short bowel syndrome. For short bowel syndrome, third parties put the market opportunity at about $8 billion by 2033. That's about 100x the size of the Mytesi HIV estimated market size.

In that deal, we got an $18 million upfront payment. So that's the enormity and of the blockbuster opportunity in terms of impact on patients, impact on the mortality, the morbidity, the cost to the healthcare system, and as we are looking to bring in additional partnerships, the type of non-dilutive dollars that we are targeting to bring into this company. We have really meaningful catalysts in the next 6-12 months, as you'll hear as I continue to go through this presentation, and a goal to bring in a license deal for rare disease. That is the key objective of the company, and as I mentioned, that is our strategy for 2026. We do have a slide that summarizes these points. Carol, I'm not sure if you are able to put that slide up.

As I mentioned, the intestinal failure program is a blockbuster market, and it's catastrophic for the patients. What is intestinal failure? Intestinal failure is a situation where the patient can't absorb their nutrients of life, their proteins, their carbs, vitamins, et cetera. They end up on parenteral nutrition, parenteral support, that's IV support, up to 20 hours a day, seven days a week. Obviously, hugely catastrophic for quality of life, but also for other health issues. It's TPN, parenteral support, but total parenteral nutrition is considered oftentimes as toxic as chemotherapy for a patient, yet necessary for them to live. Otherwise, as I mentioned, it's a lethal natural history for these patients.

For an MVID patient, if they are not diagnosed immediately when they're born, they die. If they are diagnosed, they do go on total parenteral nutrition from the moment that they're born, and they typically don't last beyond their teenage years, first of all, because of the IV interventions. There's infections, there's other problems. TPN is remarkably toxic to kidneys, to liver, to cognitive function. Patients often are on a much slower growth curve. What is the endpoint that we're looking for in our clinical trials? What's the endpoint that we're looking for with crofelemer intervention? It's reduction of TPN and parenteral support by even 5% will be meaningful. Now, I was talking with a patient advocate just a couple of weeks ago. Why is that?

Because if you can reduce even 5%, 10%, 15% the amount of time that the patient is on parenteral support, it can, for example, allow a child to go off their IV nutrition and be able to attend school. They can get most, if not all, of their parenteral support when they're asleep. It makes a very big difference in the opportunity for the patient and the patient's entire community, which includes their physician, often nurses, nutritionists, and the family all working together. Remember, every single day, these patients require parenteral nutrition. The groundbreaking results that we have already achieved in the intestinal failure area were the results of an independent proof of concept study that was conducted with crofelemer in pediatric patients in U.A.E. with intestinal failure due to microvillus inclusion disease for one patient and short bowel syndrome in two patients.

These were presented November 8th last year, 2025, at NASPGHAN, which is the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. This was presented by the study's primary investigator, Dr. Mohamad Miqdady, who has been a colleague and collaborator with the company for many years, over about eight years now. The initial results present and demonstrate disease progression modification with crofelemer through reduction of parenteral support, the key endpoint that I mentioned, in pediatric intestinal failure patients, and that reduction ranged from 12%-37%. Remember I said even 5% would be considered meaningful, and what does meaningful mean in terms of the vision, the viewpoint from regulatory agencies, FDA? Very specifically, the two pediatric short bowel syndrome intestinal failure patients who completed the treatment, the results show crofelemer reduced parenteral support between 12.5% and 15.6%.

For the MVID patient, the parenteral support needs were reduced by up to 37%. There have been no safety issues, which is consistent with the safety profile of crofelemer as demonstrated in thousands of patients in published clinical trials and in other disorders and years of commercial availability of the drug as the FDA approved Mytesi for the HIV indication. We expect the patients participating in the ongoing trial in the U.A.E. to be provided with crofelemer for the rest of their lives. Now, at this point, these patients have been treated for over a year. Initially, in the investigator-initiated trial protocol, they were treated for about three months with increasing doses, and then, again, no safety issues, they were taken off the drug and very, very quickly, in a matter of literally days.

Both the treating community, the parents, and the physicians immediately needed to put the patients back on as there was a relapse situation, which is a very important indication of benefit when you're in a non-placebo-controlled situation. So based on FDA support for a recently submitted protocol amendment for our placebo-controlled trial, which is fully enrolled for MVID, we will continue to evaluate the safety and the efficacy of crofelemer. Now this is crofelemer, but it's not Mytesi in terms of formulation. It's a highly concentrated liquid formulation that is appropriate for intestinal failure patients. As you can imagine, a pill would go right through them, and we're also talking about pediatric, in some cases, infants, to be administered this product.

In this trial, which as I mentioned is fully enrolled, the placebo-controlled trial, we filed an amendment to allow the opportunity for patients to then go into a treatment-only extension phase. Again, it's expected that we would provide product for the rest of their lives. This trial is taking place, as often happens with rare diseases, globally, so you can access the patients in the U.S., in Italy, and in the U.A.E. We're talking about an opportunity to complete our regulatory program and potentially file with the continued response, as we're seeing, for a New Drug Application based on a single-digit number of patients.

We also expect to be able to file for a Breakthrough designation with the FDA, which is an opportunity to accelerate the U.S. regulatory path and potentially qualify for the European Medicines Agency, which is like the FDA of Europe, PRIME, Priority Medicines, which can accelerate the regulatory path to approval and to market and commercialize and provide patient access in all 27 E.U. countries. As I mentioned, the target for the NDA with the FDA, the new drug application, is in the first half of 2027. MVID, again, is a devastating, catastrophic, ultra-rare pediatric disorder. The estimated worldwide prevalence is about 200 patients. This trial of crofelemer in just a small number of patients is expected to be both statistically meaningful and remarkably meaningful, huge impact for the individual patients and be supportive of registration.

There's no therapies available or even in clinical development for MVID other than life-saving parenteral support. Again, lethal natural history and underscores the need for new therapies. We do have orphan designation in the U.S. and Europe for both MVID and short bowel syndrome. Not only does that provide the opportunity and the efficiency for a smaller number of patients, by the way, significantly lower cost, smaller number of patients in clinical trials, but also for a great deal of regulatory impact and communication as we're progressing through the program, and we absolutely have been taking advantage of that. As I mentioned, coincidentally, in time, we also have the intestinal failure program enhanced by clinical proof of concept data in pediatric patients with intestinal failure due to short bowel syndrome.

We have an ongoing randomized double-blind placebo-controlled phase II study, again, of this highly concentrated liquid formulation of crofelemer in adult short bowel syndrome intestinal failure patients. Short bowel syndrome and the intestinal failure affects a significantly larger patient population, though, than MVID, although still an orphan indication. That arises from congenital anomalies, surgical resection due to Crohn's disease, cancer, accidents. Adult and pediatric patients with intestinal failure face chronic dependence on parenteral support due to the insufficient absorbent surface area of their intestines. Unlike MVID, where the patient's intestine is completely intact but not functioning, the intestinal failure situation in short bowel syndrome patients is due to their short bowel. Our intestines, a normal one is typically 20-25 ft. These could be 5 ft or less, so there's simply not enough geography to absorb the nutrients of life.

Patient population is estimated at about 12,000 patients in the United States in 2021, and this was from a third-party epidemiology study. We expect approval of crofelemer for MVID would support the development program for SBS-IF because the approval of MVID would likely help attract further partnering interests since it's the same product. It's a different indication, but it would be the same product. Safety, manufacturing, we get to benefit from the approval that we already have out there for Mytesi, for crofelemer, although in a different formulation, and then the efficacy. Very specifically, we're interested in a partner to assist in the funding for the final development and commercialization of crofelemer for MVID and short bowel syndrome IF with commercialization efforts from the partner outside the United States, addressing the global need of this population. Drugs are, of course, approved based on manufacturing and safety, which I mentioned.

Again, we get to leverage what we already have in place. The efficacy, safety, the benefit/risk ratio, with a risk of zero, the benefit, any benefit that we can show and continue to show based on our proof-of-concept data can be infinity and beyond. We established our ability to perform and close on important non-dilutive business dollar deals from where I started this presentation in January with the Future Pak deal. Again, $16 million non-diluted dollars received upfront in January, another $2 million coming, $20 million potential dollars throughout the course of the deal, over $3 million of which other dollars we have already received. In this market, the IF market is considered to be 100x larger than the HIV market.

With the clinical proof-of-concept data that we already have in hand and near-term clinical and regulatory milestones ongoing from investigator-initiated trials, from presentations, publications, from the ongoing placebo-controlled trials that we have, patients going into treatment-only extension phase, we are confident in our ability and our focus to execute upon our business development goals and strategy with our IF program and the opportunity to further bring in non-dilutive dollars. I'll now hand the discussion over to Carol for her recap of the financial highlights that we released earlier this week for the third quarter of 2025. Over to you, Carol.

Well, good morning, Lisa, and thank you all for joining our webcast today. I'll begin my review of our financials for the fourth quarter of 2025. The total net revenue for the company's prescription products, Mytesi, Gelclair, and Canalevia-CA1, non-prescription products, and license revenue, was approximately $3.2 million in the fourth quarter of 2025, representing an increase of 5% over the total net revenue in the third quarter of 2025, which totaled approximately $3.1 million, and a decrease of approximately 8% over the total net revenue in the fourth quarter of 2024, which totaled approximately $3.5 million. In 2025, approximately $11.2 million out of the company's total net revenue of $11.5 Million dollars was generated by sales of Mytesi and Canalevia-CA1.

Under the terms of the license agreement Jaguar entered with Future Pak in January 2026, Future Pak will be responsible for all commercial efforts and will receive all proceeds from the U.S. sales of Mytesi and Canalevia-CA1 as of January 12, 2026. Jaguar will be responsible for supply of product at a premium price and will recognize manufacturing revenue. Future Pak has already purchased product from Jaguar, in addition to paying $16 million to Jaguar of the upfront license fee and a $3 million payment. As we announced last month, the $3 million payment followed by Jaguar's termination of the buyback provision of the licensing agreement we entered in January with Future Pak.

This allows Future Pak to continue to commercialize Mytesi beyond five years. As Lisa mentioned, Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak, and the license agreement is in alignment with Jaguar's strategy to concentrate on crofelemer late-stage development efforts for human rare disease intestinal failure indications. Mytesi prescription volume decreased approximately 3.7% in the year 2025 over 2024, by approximately 5.8% in the fourth quarter of 2025 over the third quarter of 2025, and by approximately 12.2% in the fourth quarter of 2025 over the same period last year. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

Loss from operations increased by $15.1 million from $30.8 million in the year ended December 31, 2024, to $45.9 million in 2025. Non-GAAP recurring EBITDA for 2025 and 2024 were a net loss of $48.1 million and $35.9 million, respectively. Net loss attributable to common shareholders increased by approximately $15.1 million from $38.5 Million in the year ended December 31, 2024, to $53.6 million in 2025.

In addition to the loss from operations, the fair value of financial and hybrid instrument designation at fair value option decreased by $3.2 million from a loss of $9.5 million in the year ended December 31, 2024, to a loss of $6.3 million in 2025, primarily due to fair value adjustments in notes payable designated as FVO, or fair value option. Loss on extinguishment of debt increased by $3 million from a gain of $1.2 million in the year ended December 31, 2024, to a loss of $1.8 million in 2025, primarily due to substantial modifications to the expected payments of one royalty interest agreement, which triggered extinguishment accounting. That concludes my recap of high-level financials to the fourth quarter of 2025. I will now hand the discussion back to Lisa.

Thanks very much, Carol. Thanks, everyone, for listening. I do want to mention that while the Future Pak deal, as it brings in, as I said, non-dilutive dollars and value to fuel our rare disease program, the value to Future Pak is very important in the HIV area, the addition of Mytesi to their portfolio. Last year, Future Pak bought Theratechnologies, which has two HIV products with a remarkable overlap in the targets of physicians that are treating patients that would be expected to be experiencing GI disorder and HIV-related diarrhea. These are typically older patients. About 50% of patients living with HIV now in the United States are over the age of 50, have had the virus in their gut for over 10 years, often experiencing enteropathy and the inflammation that can lead to leaky gut and diarrhea.

They have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. Mytesi is in good hands in terms of getting to those patients with the unmet medical need and allowing us to focus on our next indications with important unmet medical need and disease, again, with a lethal natural history. The opportunity to benefit immediate symptom management, disease progression modification, and potentially extension of the patient's life. Okay. We expect to provide clinical proof of concept milestones and business development discussions throughout the rest of this year and into 2027 with a very clear goal and focus to bring in non-dilutive funds from potential licensee partner or partners.

We at Jaguar, Napo, and Napo Therapeutics remain fully energized and excited about the multiple expected near-term catalysts for crofelemer in the company, all of which we view as significant, value-enhancing, and potentially transformative for patients and for the company and all the stakeholders in the company. Have a good day. This concludes our webcast for today, and we'll see you with the next quarter.

Thank you. Ladies and gentlemen, this concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.