Jaguar Health, Inc. Stock

Good afternoon. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to matters such as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trend 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 its 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 this webcast for a variety of reasons, including those described in the forward-looking Statements and Risk Factors section of the company's Form 10-K for the year 2025, which was filed with the SEC on April 7, 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 the 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 substitute for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded.

At this time, it is now my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.

Thank you very much, Paul. Hello, and thank you all for joining our investor webcast today. My name is Lisa Conte, as you heard, I'm the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I'm also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably when I'm referring to our company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the second quarter of 2026.

The theme of today's webcast is transformation, near-term catalysts and sharp strategic focus. As many of you who have followed this company may recall, this past January, January 2026, we completed a transformative transaction, the signing of a U.S. Commercial out-license agreement with Future Pak for Mytesi, the brand name of our FDA-approved tablet formulation of crofelemer for adults living with HIV AIDS and diarrhea and for the brand name Canalevia-CA1, our conditionally approved formulation of crofelemer for dogs with chemotherapy-induced diarrhea.

We made the strategic decision to out-license Mytesi to Future Pak, first, because they had recently acquired Theratechnologies, an HIV-focused commercial company with more than 4x the commercial effort of Jaguar in the U.S., including two other HIV-related and relevant products. And secondly, to fulfill our strategic plan to bring in meaningful nondilutive dollars to help fund our sharp development focus on our pivotal stage program for our novel proprietary powder for oral solution formulation of crofelemer, so a different product of crofelemer, same active ingredient, a different product, different formulation for rare Intestinal Failure indications, rare meaning we have orphan drug designation for the Intestinal Failure indications in the United States and Europe.

We are now fully a rare disease GI company with 100% of our human development efforts sharply and strategically focused on a rare disease program. Our ultimate strategy continues to involve identifying a development and commercialization partner for this program. Just to put this in perspective, the out-license to Future Pak was $18 million upfront, primarily for the U.S. HIV market, a market with peak annual market opportunity of maybe to $50 million to $70 million annually. Intestinal Failure as an annual peak market opportunity assessed by third parties of approximately $8 billion.

To comment for a moment on two recent third-party transactions of interest, in June of 2026, Eli Lilly licensed Hanmi's Phase II GLP agonist GLP-2, not GLP-1, not the weight loss thing, GLP-2, which is for an Intestinal Failure Short Bowel Syndrome for -- in fact, for the rare disease of Short Bowel Syndrome and a deal worth up to $1.26 billion, including $75 million upfront and up to $1.185 billion in milestones plus royalties.

In August 2026, just a week ago, Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront, plus up to $500 million in milestones, a potential $1.32 billion deal centered on a proof-of-concept clinical stage. It's called a KCNT1 inhibitor for an ultra-rare genetic epilepsy, remarkably analogous to the program we have going on in intestinal failure.

So we are now focused on identifying a potential partner for rare disease indications that have a global market estimated to be in the multibillions with analogous deals that have proof of concept that is earlier stage than what we have in hand.

The near-term value driver in our Intestinal Failure development program is our lead target indication, Pediatric Microvillus Inclusion Disease. I'm going to refer to that as MVID an ultra-rare disorder, ultra-rare with no approved therapies and a lethal natural history. We've embarked on an ongoing clinical path toward a potential clinical package to be finalized by the end of 2026. So we're talking just a couple of months away and an NDA submission in mid-next year 2027.

Short Bowel Syndrome, which you'll hear me refer to as SBS, with Intestinal Failure or SBS-IF represents a larger follow-on indication using the same dosage form and physiological mechanism as Intestinal Failure with MVID patients, still a rare orphan indication. Our Intestinal Failure program represents a blockbuster global market opportunity in terms of addressing this catastrophic unmet medical need in patients and blockbuster in terms of beneficial impact to morbidity, mortality and the cost to the health care system and the financial return opportunity for all stakeholders, including, of course, shareholders. And this return opportunity is especially important to a potential corporate partner.

The global market for Short Bowel Syndrome with Intestinal Failure is, as I mentioned, is estimated to reach approximately $8 billion in 2033, and this is according to a third-party market research. And that same -- a different third party, but the third party estimates the value of the global MVID marketplace, which is an ultra-rare indication at over $1 billion in 2033, for which there are no treatments and nothing in clinical development other than crofelemer.

So I want to take a moment to describe the catastrophic impact of intestinal failure on patients and what this means for their caregiving community, which includes the health care professionals, the family members and others. Intestinal failure -- it's a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes, nutritions through IV administration --IV administration for the nutrients of life, which is all encompassed in something called TPN, Total Parenteral Nutrition with supplemental intravenous fluids. And overall TPN, the fluids it's called PN parenteral support, IV support for your nutrients of life.

Many intestinal failure patients require parenteral support, IV nutrition up to seven days a week and sometimes for 20 hours a day or more. So obviously, this is a catastrophic situation for the patient, health care, quality of life. While it is supportive, it's palliative and it is necessary for life sustenance, it's also associated with serious complications, including liver and kidney toxicities. Compromised cognitive function can have negative impact on growth and survival. And the cost is meaningful. It's estimated about $500,000 a year in the United States per patient, but the cost to the health care system with the inevitable complications, if you can imagine being on IV nutrition every single day. So the complications of infections and keeping that balance of the nutrients of life correct can top over $1 million per year per patient. And in addition, the mortality risk.

MVID is a congenital disease. So the patient is born and has a massive diarrhea and unable to absorb nutrients of life, often these patients just die right away. If the patient is not diagnosed immediately, that's what happens. If the patient is diagnosed, they will be on parenteral support for the rest of their life, again, seven days a week, 20 hours a day. The key of what we're looking for in providing adjunctive therapy to these patients is the reduction in the amount of time that they are on parenteral support. Reducing that parenteral support can have a significant impact on the massive toxicities and comorbidities that are life shortening for these patients, life-sustaining parental support that is life shortening because of the toxicities associated with them.

So the endpoint in the clinical development is the possibility to reduce parental support by even 10% to 15%. That, from a quality of life perspective, would allow the patient to receive most of their parental support at night while sleeping, preserving some quality of life, the ability to go to school during waking hours and the patient would not need to be attached to an IV to go through some of the normal daily living activities. So remember that number, 10% to 15%.

This past June, we presented groundbreaking results at the 58th Annual, it's called the European Society for Pediatric Gastroenterology, Hepatology and Nutrition Meeting, ESPGHAN, and it was in Lille, France. We presented at ESPGHAN the results of the liquid oral crofelemer, so the formulation specifically for intestinal failure to demonstrate substantial reductions in PS and PS in particular, because these are children who are growing normalized to body weight in Pediatric Intestinal Failure patients that were dosed orally for more than one year with no significant clinical or laboratory abnormalities. So basically clean, clean safety.

In one MVID patient, the weekly parenteral support requirements normalized to body weight were reduced by up to 48%. Remember the 10% to 15% I mentioned, we're talking about up to 48% following more than 12 months of crofelemer therapy. In the two SBS-IF patients, the PS requirements normalized to body weight were reduced by up to 40%, again for over a year of treatment. This is a stunning result. It's hard to express how clinically relevant this is. As I mentioned, even a 10% reduction would have been considered clinically relevant.

What was also really powerful is that after these patients were treated for about three months, they were per protocol, taken off Crofelemer, and they immediately relapsed and needed to be put back on crofelemer. So one of the strongest trial design parameters to demonstrate the true efficacy of a product. So these patients have now continued to be treated for over a year, and we expect they'll be on crofelemer for the rest of their lives, and we take great pride in providing the product for that. There have been no crofelemer-related safety issues in our intestinal failure patients or any patient treated with crofelemer and very consistent with the crofelemer that is in thousands of patients that have been in clinical trials for other disorders.

As a reminder, drugs are approved by the FDA on their benefit risk ratio. When the risk is 0, the benefit exists into perpetuity. Now we have an additional MVID patient in compassionate use being treated with oral crofelemer under an FDA-authorized expanded access program and safety and efficacy data regarding this incident was also presented at the same ESPGHAN meeting this June in Lille.

And this is a fascinating situation where the patient was diagnosed with MVID right after birth, but was too young to enroll in the enrollment criteria imposed by the FDA on Napo's clinical trial. So with the expanded access to crofelemer, the child was able to -- at three months of age or a little less, was able to get on to crofelemer. The child is now a year old, thriving, has a very active Instagram site and is almost at the 30% level in the growth curve. So in what was otherwise a catastrophic diagnosis with lethal natural history, this child is thriving. The patient has started to eat a little bit orally and is down to only 22 hours of parental or down from 22 hours-- from 22 hours on parental sport, just the first year of life down to 18 hours.

So we are committed to providing our novel crofelemer formulation as an investigational drug is deemed medically necessary by the physician or caregiver for patients in these expanded access programs intended for mitigating the sequelae from MVID [Pediatric] disease progression. The participation in expanded access programs allows us to develop relationships with this very small community of physicians, institutions, patients who are addressing intestinal failure, intestinal failure in particular associated with the ultra-rare disease of MVID before the product is approved and commercially launched.

Simultaneously, we are conducting a blinded clinical trial to evaluate the safety and efficacy of this formulation of crofelemer in pediatric patients with failure due to -- intestinal failure due to MVID. So a blinded trial simultaneously different than the results that I just spoke to, which are treatment only and unblinded, and we can see the results. So this pivotal randomized double-blind, placebo-controlled trial is fully enrolled, and taking place at clinical trial sites in the United States, Italy and the UAE.

In support of our planned new drug application filing based on patients in this trial, we submitted an amendment and received FDA authorization for a treatment-only extension phase of the trial. So after the blinded part is over, patients can continue in treatment-only extension if deemed relevant to the patients by a safety committee of which we are not a member of, that is remains blinded as well as the treating physician, the family. Every single patient was deemed relevant to go into the treatment-only extension phase. S

o the first MVID patients have entered the treatment-only extension. And with the patients from this treatment-only extension, the early patient access reserved patients that were presented, for example, at ESPGHAN and the investigator-initiated trial in UAE, we're talking about the opportunity to file for a new drug application for crofelemer for MVID, an ultra-rare disease for which we have orphan designation in the United States and Europe with essentially a single-digit number of patients.

Including the patients in our blinded trial and the MVID patients in the expanded access and investigator-initiated trials, we estimate that we're treating approximately 4% of the patient population. So while it may sound old that we're filing with a single-digit number of patients, it's relevant to other diseases given the percentage of the affected patients that we are treating. We are confident and we're passionate to bring the benefit of crofelemer to approval for all MVID patients as expeditiously as possible.

So regarding time frame, we're looking to complete enough patients in the treatment-only blinded trial. As I mentioned, all the patients from the placebo-controlled part of the trial qualified to go into the treatment only. So enough patients by the fourth quarter of this year to file for breakthrough therapy designation in the United States.

With breakthrough therapy designation, if it's granted, this would give us the opportunity for a review upon filing the new drug application of perhaps just four months after we file the NDA. The clinical package to file the NDA is expected to be ready by the end of 2026 with the actual submission of the NDA in the second quarter -- late in the second quarter of 2027. So with breakthrough designation, we could be approved in the U.S. by the end of 2027 for MVID. Europe would be a bit later. That would be in 2028 based on European Medicines Agency and some of the requirements there on reimbursement as well as risk-benefit analysis.

Intestinal failure in MVID is the same situation as intestinal failure in Short Bowel Syndrome. Short Bowel Syndrome, patients with intestinal failure, they're unable to absorb the nutrients of life because they literally have a short bowel. There's not enough surface area. Normal intestine is about 20 to 25 feet and SBS-IF intestine may be 5 feet or less. So there's literally just not enough surface area. And they too may end up on parenteral support up to 20 hours a day, seven days a week. And they have the same comorbidities, the same horrendous toxicities that you see with parenteral support in MVID patients.

We have ongoing right now a Phase II randomized double-blind, placebo-controlled trial with the same formulation, the lipid formulation of crofelemer in adult SBS-IF patients, and it's going on at various sites in Germany and Italy. This is still an orphan indication, and we do have orphan designation in the U.S. and Europe for Short Bowel Syndrome, just as we do for MVID in the U.S. and Europe. Though it is a larger patient population than MVID, which MVID arises from congenital abnormalities, SBS could be congenital abnormalities, surgical resection due to conditions like Crohn's disease, ischemia, surgical resection due to cancer, which is about 1/3 of the patients, trauma accidents. Adult and pediatric SBS-IF patients face chronic dependence on parenteral support due, again, to their insufficient absorptive surface area in intestines.

In the United States, the population is about 12,500. We're targeting the NDA filing of crofelemer for MVID in mid-2027, and we expect this NDA filing to be coincident with the timing of the availability of results from the Phase II blinded study for SBS. Because our development program for MVID involves the same formulation, this plan provides CMC, Chemistry Manufacturing Controls, basically the manufacturing stepping stone to our planned pathway for ultimate approval of crofelemer for SBS after MVID, and it will be years after MVID. But the safety would be the same, the manufacturing would be the same.

So to -- in the competition world, there's nothing for MVID. There's nothing out there in development and there's nothing for these patients. In SBS, there is a product approved and it's a GLP-2 approach. not GLP-1, that's the weight loss thing. GLP-2 is essentially a growth hormone. And what GLP-2 does is attempts to grow the intestine a bit so that parental support can be reduced by 10% to 15%. If you remember, those numbers are what's considered clinically irrelevant. Again, we blew those away with the 40% to 45% in MVID.

GLP-2 growth hormone for SBS is not standard of care. There are many side effects, and it's a growth hormone. You can't use a growth hormone. For example, you don't want to encourage growth in cancer patients or anybody with a hyperproliferative abnormal situation. And that is about 1/3 of the SBS patients. But nevertheless, what GLP-2 has done is established a business model and a regulatory approval benchmark. GLP-2s are reimbursed at about $0.5 million a year per patient in the United States.

We are seeking to have crofelemer become the standard of care for intestinal failure in both MVID and SBS. GLP-2s are only used in about 5% to 7% of patients. They can't be used on a lifelong chronic basis, whereas crofelemer could. Crofelemer could even be used in conjunction with GLP-2s. So crofelemer is really a paradigm-shifting opportunity to increase quality of life, potentially extend patients' life and have important physiological benefits and reduction of potential toxicity.

So what I've been talking about in our rare disease program, test failure program is crofelemer. Crofelemer is the active ingredient in Mytesi, but our Intestinal Failure program is not Mytesi. It is a different formulation, a different product. Mytesi is a pill -- with intestinal failure, a pill would just go right through the patient, high throughput, high transfer times, it would land in the [ toilicle ]. The oral liquid formulation, a highly concentrated lyophilized formulation of crofelemer is non-growth hormone and is a drug candidate that would be used as adjunctive therapy to parenteral support through a first-in-class physiological mechanism of action, reducing liquid stool output and therefore, reducing parenteral support needs and the associated toxicity associated with that.

It's also important to note that crofelemer is defined as an antisecretory, first-in-class antisecretory drug. It's not an anti-diarrheal. It's locally acting on intestinal clonidine channel and normalization reduces intestinal chloride-driven fluid accumulation. And so we're getting a bit technical here, but it results in reduction of the electrolyte and the fluid losses and the concordant parenteral support reductions, which is the clinically relevant endpoint in both MVID and Short Bowel Syndrome Intestinal Failure.

We've established our ability to perform and close an important non-dilutive business development deal in January with the Future Pak deal, as I mentioned. We got -- we were provided $16 million non-dilutive capital in January upon closing of the agreement. We satisfied some specific post-closing conditions and received an additional non-dilutive $2 million, which was part of the upfront fee from Future Pak. We continue to be the manufacturer of crofelemer for Mytesi and the Canalevia formulations for Future Pak and per the terms of the opportunity, and that is at a profit. So it's a profit center for us. We are a centralized manufacturer. And per the terms of the agreement, we have an opportunity to receive up to another $17 million in additional milestone payments, future payments, again, non-dilutive.

The intestinal failure market that we are now sharply focused on is considered to be approximately 100x larger than the HIV diarrhea market. So with those numbers that I told you, basically $18 million upfront, $17 million additional milestones, we're talking about a market opportunity 100x larger.

With the clinical proof-of-concept data we have in hand and the very near-term clinical and regulatory milestones ongoing, we are confident in our ability to execute our business development goals in our Intestinal Failure program to further the opportunity to bring in serious, meaningful, valuable non-dilutive dollars commensurate with the market size, the serious unmet medical need and driven first and foremost by the benefit and the benefit risk, with risk being nearly 0 that we are providing to the patients with no alternative treatment.

Just briefly, I should mention it's the major focus of our business is human health, of course, and our rare disease program is 100% of our human focus. We do have a small business in animal health, and we're pleased to announce recently that we're planning for the anticipated commercial launch very, very shortly of a product called Neonorm Dog. It's a new extension of Jaguar's nonprescription Neonorm franchise for companion animals.

Neonorm Dog is designed to provide dog owners with access to a plant-based non-prescription product intended to support normal stool consistency, GI fluid balance in dogs. It's also an antisecretory mechanism of action. And what we're doing is leveraging the relationships that we built when we were conducting the promotion and the education around Canalevia-CA1 before it was licensed to Future Pak. Canalevia-CA1, again, was our FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs.

The Neonorm franchise currently includes other Neononorms, non-prescription products for foals and for calves, plant-based products to support proper hydration and bowel health in pre-weaned foals and calves. Many of the vets that we spoke with when we were educating and promoting around chemotherapy-induced diarrhea indicated a strong unmet need for addressing general watery diarrhea in dogs of any cause. And now with Neonorm Dog, we will have something to offer them and to the doggy parents with easy availability of Neonorm Dog through online and animal health retail channels, not just from their vet, including Amazon and Chewy, which is an absolutely fantastic place for animal health products.

So with that description, you can hear that we're very excited, very enthused about what we're doing, and I'm going to hand the discussion over to Carol Lizak, now our CFO, for her recap of the financial highlights of the second quarter of 2026. And just before I turn it over to remind everybody that for many years, we were selling Mytesi ultimately into the distributors and had a sales force promoting directly to the physicians who are prescribing to patients. At this point, we are supplying to Future Pak. And so there's a much different impact on the sales and the revenue numbers that we are reporting.

Carol, let me turn it over to you.

Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the second quarter of 2026.

License and grant revenue, as Lisa mentioned, Jaguar entered a U.S. commercial licensing agreement with Future Pak in January 2026, and Future Pak is now the exclusive U.S. marketer for the company's Mytesi and Canalevia-CA1 products.

License revenues for the initial $16 million upfront payment in addition to the $3 million payment for early termination of the buyback option under this agreement were recognized by the company in the first quarter of 2026. As announced in August 2026, Jaguar has satisfied the closing conditions required to receive payment of the non-dilutive $2 million holdback amount of the upfront fee from Future Pak. Napo remains the manufacturer of crofelemer and Mytesi and supplies the product to Future Pak at cost plus terms.

Additionally, the company recognized license fees of $43,000 in the second quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of June 30, 2026, the total deferred revenue associated with this contract amounts to $468,000.

Federal grant revenue recognized in the second quarter of 2026 for the clinical trial study related to the treatment of Chemotherapy-Induced Diarrhea, or CID in dogs was $25,520 and none last year.

For prescription product revenue net, the total net revenue for the company's prescription products, that's Mytesi, Gelclair and Canalevia-CA1 was approximately $1.2 million in the second quarter of 2026, which was comprised primarily of sales of Mytesi at cost plus to Future Pak. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pak. Again, 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. Future Pak is privately held and does not report Mytesi sales.

Compared to the second quarter of 2025, the number of Mytesi bottles the company sold in the second quarter of 2026 increased significantly and commercial costs were substantially decreased. The decision to enter a commercial license agreement with Future Pak 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.

The total net revenue for the company's prescription products in the second quarter of 2026 represents a decrease of approximately 2% compared to the first quarter of 2026 when total net revenue for prescription products was approximately $1.2 million. Additionally, prescription products net revenue decreased by 60% compared to the second quarter of 2025 when total revenues amounted to about $2.9 million.

The loss from operations decreased, however, by about $400,000, going from a loss of $8 million in the quarter ended June 30, 2025, to a loss of $7.6 million in the quarter ended June 30, 2026. This change was primarily due to a $1.7 million decrease in product net revenue but was offset by a reduction in operating expenses of approximately $2.1 million, largely attributed to the Future Pak licensing agreement.

For non-GAAP recurring EBITDA for the second quarters of 2026 and 2025 were a net loss of about $8.4 million and $7.9 million, respectively. Net loss attributable to common shareholders increased by approximately $2.3 million from a loss of $10.4 million in the quarter ended June 30, 2025, to a loss of $12.7 million in the quarter ended June 30, 2026.

In addition to the loss from operations, interest expense increased by $176,000 from a $15,000 interest income for the quarter ended June 30, 2025, to about $161,000 in the quarter ended June 30, 2026, due to interest expenses accrued on notes. The fair value of financial and hybrid instruments designated as FVO or Fair Value Option increased by about $900,000 from a loss of $1.1 million in the quarter ended June 30, 2025, to a loss of $1.9 million in the quarter ended June 30, 2026, and again, primarily due to fair value adjustments in liability classified warrants and notes payable designated as FVO.

Loss on extinguishment of debt increased by $1.7 million from a loss of $1.8 million in the quarter ended June 30, 2025, to a loss of $3.5 million during the three months ended June 30, 2026, due to significant modifications to qualify for extinguishment accounting with none recorded in the same period in 2025.

Well, that concludes my recap of high-level financials for the second quarter of 2026. I will now hand the discussion back to Lisa. Thank you.

Thanks, Carol. We'll wrap this up quickly. As a recap, our Intestinal Failure program will continue to provide clinical proof-of-concept milestones and is the subject of ongoing business development discussions with the potential to bring in meaningful non-dilutive dollars 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 perpetual IP intestinal protection shield, exclusivity shield as there is no practical pathway to bring a generic to market.

So even though we have a very robust and extensive IP patent strategy, just like any other pharmaceutical company, it sort of the price of being in the business, we do have approximately 185 issued patents. We essentially have exclusivity perpetually to infinity and beyond, which is very powerful when doing terminal value calculations with, for example, potential commercial partners. You don't have that patent cliff that you often hear about and read about with other companies.

So as you can probably tell, all members of the Jaguar, Napo, Napo Therapeutics family are fully engaged, fully energized and excited about the multiple near-term expected catalysts on the regulatory and clinical side for crofelemer and on the business side, all of which we view as significant, extremely value-enhancing and potentially transformative for patients and for diseases with completely unmet medical needs. Everything we do at Jaguar, Napo and Napo Therapeutics is rewarding and our efforts to address such truly devastating rare intestinal failure diseases has really provided satisfaction on another level.

This concludes our webcast for today. Thank you very much for joining, and we'll see you in the next quarter.

This concludes today's conference. We thank you again for your participation. You may disconnect your lines at this time.

[Audio Gap] 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 its 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.

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 7, 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.

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, January 2026, with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer for adults living with HIV AIDS and experiencing diarrhea and 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 4x the commercial effort of Jaguar in the United States; and secondly, to fulfill our strategic plan to bring in meaningful nondilutive dollars to fund our sharp development focus on our pivotal stage program for our novel proprietary powder for oral solution formulation of crofelemer, so a different formulation than the Mytesi tablet, 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. Our 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 health care systems and blockbuster in terms of 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 of intestinal failure to patients in their caregiving community, their health care providers, doctors, nurses, nutritionists, family members and others involved in the care taking. 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 fluid, which altogether constitute parenteral support, PS, parenteral support.

Many intestinal failure patients require parenteral support up to 7 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, parental support, is estimated at about $500,000 per year in the United States and the cost to the health care system with the inevitable complications can top $1 million per year per patient. The key benefit to IF patients on parental support and the key endpoint in clinical development is the possibility to reduce PS by even 10% to 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 parental 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, with 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 pediatric intestinal failure patients that ranged from 12% to 37%.

Specifically, in the 2 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 treatments, parenteral support needs were reduced by up to 37%. It's worth saying, again, 37%, a remarkable result. Multiple patients with intestinal failure due to either MVID or SBS who are taking part in the trial in the UAE have now been treated for more than 1 year and longer-term data will be presented at the Annual Meeting of ESPGHAN, another mouthful, the European -- not North American, the 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 9 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 United States, Italy and the UAE.

We expect the rest of the enrolled patients to enter the treatment-only phase over the next 2 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 here and 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. And 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 United States would give an approval time line of 4 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 parental support through its unique first-in-class physiological mechanism of action of reducing liquid stool output, thus reducing parental 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 United States. We established our ability to perform and close important nondilutive business development deals as we did in January of this year with Future Pak with $16 million nondilutive 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.

The intestinal failure market is considered to be approximately 100x larger than the HIV diarrhea market. So 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 nondilutive 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. Buoyed 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, nonprescription 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 to 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 $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 instruments 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 3 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 nondilutive funds from potential licensee partners. Importantly, crofelemer 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. [Operator Instructions] 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 Factors sections of the Company's Form 10-K for the year 2025, which was filed with the SEC on April 7, 2026, and its other filings with the SEC, which are available in 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, except as required by law -- I'm sorry, 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. And 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 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. So as usual, I may use the words Jaguar and Napo interchangeably to refer to the Company. And after I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the fourth quarter of 2025 last year. And, 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 nonprescription 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. And 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 upfront, 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. So, 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 natural -- 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, placebo-controlled trial for short bowel syndrome. For short bowel syndrome, third parties put the market opportunity at about $8 billion by 2023. 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 health care 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 to 12 months, as you'll hear as I continue to go through this presentation and a goal to license -- 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. Terrific. Terrific. As I mentioned, the intestinal-failure program is a blockbuster market, and it's catastrophic for the patients.

What is intestinal failure? The intestinal failure is a situation where the patient can't absorb their nutrients of life. Their proteins, their carbs, vitamins, et cetera. So they end up on parenteral nutrition, parenteral support, that's IV support up to 20 hours a day, 7 days a week. So, 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. And 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.

But TPN is remarkably toxic to kidneys, to liver, to cognitive function, patients often are on a much slower growth-curve. So, 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. And, I was talking with a patient advocate just a couple of weeks ago. And why is that? Because if you can reduce even 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. So, it makes a very, very big difference in the opportunity for the patient and the patient's entire community, which includes the physician, often nurses, nutritionists, and the family, all working together.

Remember, every single day, these patients require parenteral nutrition. So, 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 UAE with intestinal failure due to microvillus inclusion disease for one patient and short bowel syndrome in two patients, and [indiscernible] were presented November 8 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. Mohammed Miqdady, who has been a colleague and collaborator with the Company for many years, over about 8 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% to 37%. And remember, I said even 5% would be considered meaningful and what is meaningful means in terms of the vision, the viewpoint from regulatory agencies, FDA.

Very specifically, the 2 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%, and 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 -- in other disorders and years of commercial availability of the drug at the FDA -- as the FDA-approved Mytesi for the HIV indication.

We expect the patients participating in the ongoing trial in the UAE 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 3 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 community, and 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 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 amendment to allow the opportunity for patients to then go into a treatment-only extension phase. And again, it's expected that we would provide product for the rest of their lives. And this trial is taking place as often happens with rare diseases globally, so you can access the patients. So, in the United States, in Italy, and in the UAE. We're talking about an opportunity to complete our regulatory program and potentially file with 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 from -- 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 EU countries. As I mentioned, the target for the NDA with the FDA, the New Drug Application is in the first half of 2027, MVIC against devastating, catastrophic, ultra-rare pediatric disorder; the estimated worldwide prevalence is about 200 patients.

So, 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.

And 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 than MVID, although still an orphan indication. And 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 absorptive surface area of their intestine. So, 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 intestine, the normal one is typically 20, 25 feet. These could be 5 feet 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 interest, 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 and the efficacy, safety, the benefit-risk ratio, with a risk of 0, 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 deals from where I started this presentation in January with the Future Pak deal. Again, $16 million non-dilutive dollars received upfront in January, another $2 million coming, $20 potential million 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 further bring in 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 nonprescription 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 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 the 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 buy-back provision of the Licensing Agreement we entered in January with Future Pak. This allows Future Pak to continue to commercialize Mytesi beyond 5 years. As Lisa mentioned, Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak, and the Licensing 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 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 at 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 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 2 HIV programs -- 2 HIV products, excuse me, with a remarkable overlap in the targets, the 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. And they -- so they have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. So 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.

So 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 licensing partner or partners. We, at Jaguar, Napo, and Napo Therapeutics 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, 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.

Greetings, and welcome to the Jaguar Health's Investor Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

Before I turn the call over to management, I'd like to remind you that management 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, product initiatives, including products in the development stage, which may 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 its 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 this 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 year 2024, which was filed March 31, 2025, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's webcast. 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 the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss or not substitute for or superior to, measures of financial performance and performance 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 Officer (sic) [Chief Executive Officer]. Lisa, the floor is yours.

Thank you very much. Appreciate that introduction. Hello to everybody. Good morning. My name is Lisa Conte and I'm, Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals, and I'm also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the word Jaguar and Napo interchangeably as I refer to our company. And after I speak this morning, our CFO, Carol Lizak, will provide a recap of the financial highlights for the third quarter of 2025.

And I'm going to kick off by once again stealing Carol thunder as we are pleased to report that our combined net third quarter 2025 revenue of approximately $3.1 million for prescription and nonprescription products including license revenue, increased approximately 4% versus the net Q2 2025 of approximately $3 million. I'm also happy to report that 2025 continues to be the year of convergence of key clinical and regulatory catalysts for Jaguar. Catalysts that we feel will be transformative in terms of the value that they bring to all stakeholders in the company from patients, very importantly from patients, to shareholders also very important.

Simply put, with the recent achievement of these catalysts, our strategy continues to be to negotiate business development partnerships for licensed rights to the development and commercialization of our Human and Animal late-stage health products with the goal of generating non-dilutive funding for Jaguar. We have three key late-stage initiatives that are the subject of business development negotiations.

The first is our orphan indications of crofelemer for intestinal failure associated with the congenital diarrheal disease referred to as MVID, microvillus inclusion disease. I'm going to refer to it as MVID and short bowel syndrome, which I'm going to refer to as SBS. And this program refers to crofelemer, though, not our commercialized Mytesi formulation of crofelemer. Crofelemer in a distinct novel, highly concentrated liquid formulation, which is appropriate for the patient condition -- into a liquid formulation from a lyophilized cake. So what is intestinal failure?

It's a debilitating lifelong condition that requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of something referred to as TPN, total parenteral nutrition, with supplemental intravenous fluids, which together constitute parenteral support. As you can imagine, already, this sounds terrible. These are patients who can't absorb their nutrients of life, their protein, carbs, et cetera. So they are living on IV nutrition.

Most intestinal failure patients require parenteral support up to 7 days a week and sometimes for 20 hours or more a day, hooked up to IV nutrition. Clearly, this is a catastrophic healthcare situation, quality of life situation. Short bowel syndrome is a rare disease of approximately 400 -- 40,000 patients globally. And for this indication, Jaguar has received orphan drug designation in the United States and in Europe. MVID, intestinal failure MVID patients, this is an ultra-rare disease of approximately 100 to 200 patients globally, and we have also received orphan drug designation in the U.S. and Europe.

Infants that are born with this genetic defect have a lethal natural history. They do not become adults. They only survive if immediately receiving TPN, total parenteral nutrition, as I mentioned, parental support which has many toxicities associated with it including liver and kidney toxicity, neurodevelopment delay, many more which often become life-threatening.

Crofelemer has been shown to have a groundbreaking reduction of parenteral support of up to 37%. And this is important, as you can imagine, for getting -- reducing the amount of time on toxic TPN and parenteral support. This result was presented last week at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition referred to as NASPGHAN. And it's an annual meeting in Chicago, and it was -- the results were presented by the study's primary investigator in the investigator-initiated trial, Dr. Mohamad Miqdady.

This is important because the reduction of parenteral nutrition and parenteral support is both potentially life-extending, life-saving and disease progression modifying and provides an opportunity for improved quality of life in this otherwise catastrophic medical and disease situation for the patient and quite frankly, the entire family of the child and his or her caregiving team. This unprecedented result is especially compelling given that no approved treatments exist for MVID, and we're not aware of any approach even in development for MVID.

Additionally, as presented at NASPGHAN were two short bowel syndrome patients surviving on parenteral support, parenteral nutrition and parenteral support, which similarly had reductions of approximately 12% in their parenteral support. This result is equally important for the same reason for the opportunity to reduce the toxicity associated with the parenteral support. And also, while some short bowel syndrome patients do have an opportunity to be treated with a growth hormone approach to potentially grow their short bowel. And as an aside, by the way, growth hormone is not a standard of care as many side effects itself. And additionally, it's not even possible in an MVID patient as MVID patients have fully intact guts. They're simply not functioning, so there's nothing to grow.

But anyway, that short bowel syndrome, approximately 1/3 of the short bowel syndrome population are patients with surgical reasons for their short bowel and have adaptation issues during which they cannot receive a growth hormone and/or may have a hyper-proliferative circumstance such as cancer and therefore, are definitely not candidates for growth hormone approach.

Once again, crofelemer is demonstrating proof of concept in an orphan population with no treatment alternatives, nothing in development. And once again, this is a distinct product from Mytesi, the same active ingredient in crofelemer and will be commercialized globally under a business model associated and appropriate for the incentives for rare diseases.

I'll now discuss our other core crofelemer development program, cancer therapy related diarrhea, CTD, a planned label extension of supplemental NDA for the already FDA-approved Mytesi product. This program -- and again, it's a distinct product from the [indiscernible] highly concentrated liquid formulation is also the subject of ongoing business development negotiations. The key clarifying and coordinating event, once again a separate Type C meeting with the FDA in May of 2025 discussing an expedited pathway for approval in metastatic breast cancer patients based on supportive data of prophylaxis of cancer therapy-related diarrhea in breast cancer patients from the completed Phase III [on-target] trial, which was presented at San Antonio Breast Cancer Symposium in December of 2024.

We're going to combine this with anticipated data from a pivotal randomized withdrawal treatment trial in metastatic breast cancer patients to be initiated in early 2026. In our experience, a randomized withdrawal trial is the optimal design for product that works. And it's a clinical trial design where participants first receive an active treatment and then when, if, they respond, randomly assigned to either continue the active treatment or receive placebo.

As a reminder, this trial is with the same formulation and dose as the approved Mytesi for HIV-related diarrhea for which, of course, chronic safety and manufacturing regulatory hurdles have already been approved. Chronic safety or any safety and manufacturing are the two most common reasons why NDAs fail. Again, those have already been achieved with Mytesi. An efficacy end point potentially expands the indication of Mytesi to cancer therapy-related diarrhea under a supplemental NDA and cancer therapy-related diarrhea is a blockbuster opportunity for the patients, of course, and the market opportunity.

There are approximately 160,000 metastatic breast cancer patients in the United States, many of whom are on diarrhea causing targeted therapies for the rest of their lives, which thankfully are becoming 5, 10, 15 years of survival sometimes. We have filed for orphan drug designation for metastatic breast cancer indication. Approximately 40% of patients go off their life-saving targeted therapies, specifically because of diarrhea. And now crofelemer has the opportunity to benefit not only patient quality of life, dignity and comfort as important as those supportive care impacts are, though, also impact the outcome of their -- the successful outcome of their cancer therapy.

Moving along now to Animal Health side of our business. Our primary activity for Canalevia, our prescription drug candidate of crofelemer, Canalevia is an animal formulation indication that is FDA conditionally approved under the name Canalevia CA-1 for the treatment of chemotherapy-induced diarrhea in dogs. And our primary activity is negotiating with potential partners with which to collaborate to achieve three parallel goals for the drug, expand the U.S. indication for chemotherapy-induced diarrhea in dogs, to the treatment of general diarrhea in dogs, obtain approval in the European Union for Canalevia for general diarrhea in dogs and based on an existing Jaguar study that already exists. And maintain continuity of availability in the United States of Canalevia for the treatment of chemotherapy-induced diarrhea in dogs for which it is already approved again.

Remarkably, a cancer patient in the United States experiencing diarrhea can have crofelemer promoted and prescribed if that patient is a dog, a human, not yet. I'm pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally. This is our third ongoing business development negotiation with the goal of bringing nondilutive dollars to recognize the contribution to late-stage drug development and risk reduction Jaguar has achieved with crofelemer for various indications.

Timeline associated with these activities for intestinal failure based on a Type C meeting, a distinct meeting from the cancer meeting that we had with the FDA on October 2. We laid out a pathway for potential expedited review based on continued results like we're seeing in the MVID patient for having data that's fileable by potentially the end of 2026, literally based on a single-digit number of patients because of the ultra-rare nature of the disease and the lethal natural history of the disease, also looking next year for breakthrough designation in the United States and PRIME in Europe, programs that help get products approved in an expedited way for ultra-rare disease situation.

For cancer therapy-related diarrhea, we would look to complete the trial for the randomized withdrawal by the end of 2026 as well in support of a supplemental NDA filing. So that would be two potential NDA filings from data at the end of 2026 on the Human side. On the Animal Health side, we're looking to close an animal health partnership in the very near future.

I'll now hand the discussion over to Carol, our CFO, for a recap of the financial highlights for the third quarter of 2026. Take it away, 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 third quarter of 2025. The combined net third quarter 2025 revenue of approximately $3.1 million for prescription and nonprescription products, including license revenue, increased approximately 4% versus net second quarter 2025 revenue of approximately $3 million and equaled net third quarter of 2024 revenue of approximately $3.1 million.

Mytesi prescription volume increased by approximately 0.9% in the third quarter of 2025 over the second quarter of this year and Mytesi prescription volume in the third quarter of 2025 decreased by 3.6% compared to the volume in the third quarter 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 decreased by $24,000 from $7.2 million in the third quarter of September 30, 2024, to] [$7.3] million during the same period this year. Non-GAAP recurring EBITDA for the third quarters of 2025 and 2024 were a net loss of $8.9 million and $9.2 million respectively. Net loss attributable to common shareholders decreased by $352,000 from $9.9 million in the quarter ended September 30, 2024, to $9.5 million in the same period in 2025.

And that concludes my recap of high-level financials for the third quarter of 2025. I will now hand the discussion back to Lisa.

Thanks, Carol. Okay. To all members of the Jaguar, Napo, Napo Therapeutics family, we 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 as I mentioned, all stakeholders, including our shareholders. Pharmaceutical development is a long-term outcome. And these catalysts represent the convergence of key potential inflection points in our major programs that we've worked on for years. And we expect these catalysts to lead to significant collaborations, business development and licensing deals, and the opportunity to bring in nondilutive dollars to support bringing these late-stage products and programs to regulatory approval and reimbursed patient access.

This concludes our webcast for today. Thank you all for joining. Have a wonderful Thanksgiving and holiday with your families. And we'll get together again next quarter. Thank you.