Q2 2026 Jaguar Health Inc Earnings Call
Speaker #1: 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 trends, and product initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements.
Operator: Good afternoon. Before I turn the call over to management, I would 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 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.
Operator: Good afternoon. Before I turn the call over to management, I would 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 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.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: 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.
Operator: 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 7 April 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.
Operator: 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 7 April 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.
Speaker #1: These 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 contained in this presentation to reflect new information, future events, or otherwise.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: 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.
Operator: These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it is 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.
Operator: These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it is 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.
Speaker #1: 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.
Speaker #1: Lisa, the floor is yours.
Speaker #2: Oh, thank you very much, Paul. Hello, and thank you all for joining our investor webcast today. My name is Lisa Conte, as you heard.
Lisa Conte: Oh, 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 am the founder, president and CEO of Jaguar Health and our wholly-owned subsidiary, Napo Pharmaceuticals. I am also the chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably when I am referring to our company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the Q2 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 2026, we completed a transformative transaction.
Lisa Conte: Oh, 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 am the Founder, President and CEO of Jaguar Health and our wholly-owned subsidiary, Napo Pharmaceuticals. I am also the chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably when I am referring to our company. After I speak, our Chief Financial Officer, Carol Lizak, will provide a recap of the financial highlights for the Q2 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 2026, we completed a transformative transaction.
Speaker #2: 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.
Speaker #2: As usual, I may use the words Jaguar and Napo interchangeably when referring to our company. After I speak, our CFO, Carol Isaac, will provide a recap of the financial highlights for the second quarter of 2026.
Speaker #2: 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.
Speaker #2: The signing of a U.S. commercial out-license agreement with FuturePAC for the Mitessi brand name of our FDA-approved tablet formulation of chlorphenamide for adults living with HIV/AIDS and diarrhea.
Lisa Conte: The signing of a US 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. 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 Inc., an HIV-focused commercial company with more than four times the commercial effort of Jaguar in the US, including two other HIV-related and relevant products. Secondly, to fulfill our strategic plan to bring in meaningful non-dilutive 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.
Lisa Conte: The signing of a US 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. 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 Inc., an HIV-focused commercial company with more than four times the commercial effort of Jaguar in the US, including two other HIV-related and relevant products. Secondly, to fulfill our strategic plan to bring in meaningful non-dilutive 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.
Speaker #2: And for the brand name Canalidia CA1, our conditionally approved formulation of chlorphenamide for dogs with chemotherapy-induced diarrhea. We made the strategic decision to out-license Mitessi to Future PAC first, because they had recently acquired their technologies and are an HIV-focused commercial company with more than four times the commercial effort of Jaguar in the US, including two other HIV-related and relevant products.
Speaker #2: And secondly, to fulfill our strategic plan to bring in meaningful non-dilutive 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.
Speaker #2: Same active ingredient, 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.
Lisa Conte: 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 our 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 US HIV market, a market with peak annual market opportunity of maybe $50 to $70 million annually. Intestinal failure has 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 2026, Eli Lilly and Company licensed Hanmi Pharm's phase II GLP-2 antagonist. Not GLP-1, not the weight loss thing.
Lisa Conte: 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 our 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 US HIV market, a market with peak annual market opportunity of maybe $50 to $70 million annually. Intestinal failure has 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 2026, Eli Lilly and Company licensed Hanmi Pharm's phase II GLP-2 antagonist. Not GLP-1, not the weight loss thing.
Speaker #2: We are now fully a rare disease GI company, with 100% of our human development effort sharply and strategically focused on a rare disease program.
Speaker #2: 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 FuturePAC was $18 million upfront, primarily for the U.S. HIV market—a market with peak annual market opportunity of maybe $50 to $70 million annually.
Speaker #2: Intestinal failure has an annual peak market opportunity assessed by third parties of approximately $8.8 billion. To comment for a moment on two recent third-party transactions of interest—in June of 2026, Eli Lilly licensed Hamiz Phase II GLP and agonist GLP-2.
Speaker #2: Not GLP-1, not the weight loss thing. GLP-2, which is for intestinal failure, short bowel syndrome— in fact, for the rare disease of short bowel syndrome— and a deal worth up to $1.26 billion.
Lisa Conte: GLP-2, which is for an intestinal failure, short bowel syndrome. In fact, for the rare disease of short bowel syndrome, in 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 is called a KCNT1 inhibitor for an ultra-rare genetic epilepsy. Remarkably analogous to the program we have going on in intestinal failure. We are now focused on identifying a potential partner for rare disease indications that have a global market estimated to be in the multi-billions with analogous deals that have proof of concept that is earlier stage than what we have in hand.
Lisa Conte: GLP-2, which is for an intestinal failure, short bowel syndrome. In fact, for the rare disease of short bowel syndrome, in 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 is called a KCNT1 inhibitor for an ultra-rare genetic epilepsy. Remarkably analogous to the program we have going on in intestinal failure. We are now focused on identifying a potential partner for rare disease indications that have a global market estimated to be in the multi-billions with analogous deals that have proof of concept that is earlier stage than what we have in hand.
Speaker #2: Including $75 million upfront and up to $1.185 billion in milestones, plus royalties. In August of 2026, just a week ago, Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront, plus up to $500 million in milestones.
Speaker #2: A potential $1.32 billion deal centered on a proof-of-concept clinical stage—it’s called a KCNT1-1 inhibitor—for an ultra-rare genetic epilepsy. Remarkably analogous to the program we have going on in intestinal failure.
Speaker #2: So we are now focused on identifying a potential partner for rare disease indications that have a global market estimated to be in the multi-billions, with analogous deals that have proof of concept at an earlier stage than what we have in hand.
Speaker #2: 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 with no approved therapies and a lethal natural history.
Lisa Conte: The near-term value driver in our intestinal failure development program is our lead target indication, pediatric microvillous inclusion disease. I am going to refer to that as MVID, an ultra-rare disorder. Ultra-rare, with no approved therapies and a lethal natural history. We have embarked on an ongoing clinical path toward a potential clinical package to be finalized by the end of 2026, so we are talking just a couple of months away, and an NDA submission in mid next year, 2027. Short bowel syndrome, which you will hear me refer to as SBS with intestinal failure, 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 orphaned indication.
Lisa Conte: The near-term value driver in our intestinal failure development program is our lead target indication, pediatric microvillous inclusion disease. I am going to refer to that as MVID, an ultra-rare disorder. Ultra-rare, with no approved therapies and a lethal natural history. We have embarked on an ongoing clinical path toward a potential clinical package to be finalized by the end of 2026, so we are talking just a couple of months away, and an NDA submission in mid next year, 2027. Short bowel syndrome, which you will hear me refer to as SBS with intestinal failure, 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 orphaned indication.
Speaker #2: 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.
Speaker #2: And an NDA
Speaker #1: Submission in mid next year . 2027 . Short bowel syndrome , which you'll hear me refer to as SBS with intestinal failure . SBS if represents a larger follow on indication using the same dosage form and physiological mechanism as intestinal failure , with mvid .
Speaker #1: 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 healthcare system .
Lisa Conte: 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 beneficial impact to morbidity, mortality, and the cost to the healthcare system. And in the financial return opportunity for all stakeholders, including, of course, shareholders. This return opportunity is especially important to a potential corporate partner. The global market for Short Bowel Syndrome with Intestinal Failure, as I mentioned, is estimated to reach approximately $8 billion in 2033, and this is according to a third-party market research. A different third party, but a 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.
Lisa Conte: 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 beneficial impact to morbidity, mortality, and the cost to the healthcare system. And in the financial return opportunity for all stakeholders, including, of course, shareholders. This return opportunity is especially important to a potential corporate partner. The global market for Short Bowel Syndrome with Intestinal Failure, as I mentioned, is estimated to reach approximately $8 billion in 2033, and this is according to a third-party market research. A different third party, but a 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.
Speaker #1: And in the financial return opportunity for all stakeholders , including , of course , shareholders . And this return opportunity is especially important to potential corporate partner .
Speaker #1: The global global market for short bowel syndrome with . With intestinal failure is , as I mentioned , is estimated to reach approximately $8 billion in 2033 .
Speaker #1: And this is according to a third party market research and that same at different third party . But a third party estimates the value of the global MDD 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 .
Speaker #1: So I want to take a moment to describe the catastrophic impact of intestinal failure and patients and what this means for their caregiving community , which includes the healthcare professionals , the family members , and others and others Intestinal failure is a debilitating condition that often requires patients to receive life sustaining fluids , electrolytes , nutrition through IV administration IV administration for the nutrients and life , which is all encompassed in something called TPN total parenteral nutrition with supplemental intravenous fluids and overall TPN with fluids is called PM Parental Support IV support for your nutrients of life Many intestinal failure patients require parental support .
Lisa Conte: 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 healthcare professionals, the family members, and others. Intestinal failure, it is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes, nutritions through IV administration. IV administration for the nutrients in life, which is all encompassed in something called TPN, total parenteral nutrition, with supplemental intravenous fluids. Overall TPN with fluids is 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. Obviously, this is a catastrophic situation for the patient, healthcare, quality of life.
Lisa Conte: 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 healthcare professionals, the family members, and others. Intestinal failure, it is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes, nutritions through IV administration. IV administration for the nutrients in life, which is all encompassed in something called TPN, total parenteral nutrition, with supplemental intravenous fluids. Overall TPN with fluids is 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. Obviously, this is a catastrophic situation for the patient, healthcare, quality of life.
Speaker #1: 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's health care quality of life.
Speaker #1: Well , it is supportive . It's palliative , and it is necessary 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 .
Lisa Conte: While it is supportive, it is palliative, and it is necessary for life sustenance, it is also associated with serious complications, including liver and kidney toxicities, compromised cognitive function, can have negative impact on growth, and survival. The cost is meaningful. It is estimated about $500,000 a year in the United States per patient, but the cost to the healthcare system with the inevitable complications, if you can imagine being on IV nutrition every single day. The complications of infections and keeping that balance of the nutrients of life correct can top over $1 million per year per patient. In addition, the mortality risk. MVID is a congenital disease. The patient is born and has massive diarrhea and unable to absorb nutrients of life. Often, these patients just die right away. If the patient is not diagnosed immediately, that is what happens.
Lisa Conte: While it is supportive, it is palliative, and it is necessary for life sustenance, it is also associated with serious complications, including liver and kidney toxicities, compromised cognitive function, can have negative impact on growth, and survival. The cost is meaningful. It is estimated about $500,000 a year in the United States per patient, but the cost to the healthcare system with the inevitable complications, if you can imagine being on IV nutrition every single day. The complications of infections and keeping that balance of the nutrients of life correct can top over $1 million per year per patient. In addition, the mortality risk. MVID is a congenital disease. The patient is born and has massive diarrhea and unable to absorb nutrients of life. Often, these patients just die right away. If the patient is not diagnosed immediately, that is what happens.
Speaker #1: And the cost is meaningful. It's estimated to be about $500,000 a year in the United States per patient. But the cost to the healthcare system with the inevitable complications—if you can imagine being on IV nutrition every single day.
Speaker #1: So the complications of infections and keeping that balance of the nutrients of life correct can top over $1 million per year per patient.
Speaker #1: And in addition, the mortality risk. MVP is a congenital disease, so the patient is born and has the massive diarrhea and is unable to absorb nutrients of life.
Speaker #1: 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.
Lisa Conte: 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 are looking for in providing adjunctive therapy to these patients is a 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 parenteral support that is life-shortening because of the toxicities associated with them. The endpoint in the clinical development is the possibility to reduce parenteral support by even 10% to 15%.
Lisa Conte: 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 are looking for in providing adjunctive therapy to these patients is a 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 parenteral support that is life-shortening because of the toxicities associated with them. The endpoint in the clinical development is the possibility to reduce parenteral support by even 10% to 15%.
Speaker #1: Again , seven days a week , 20 hours a day The key of what we're looking for in in providing adjunctive therapy to these patients is a reduction in the amount of time that they are on parental support , reducing that parental support can have a significant impact on the massive toxicities and comorbidities that are life shortening for these patients .
Speaker #1: 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% .
Speaker #1: 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 .
Lisa Conte: That, from a quality of life perspective, would allow the patient to receive most of their parenteral 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. Remember that number, 10% to 15%. This past June, we presented groundbreaking results at the 58th Annual, it is called the European Society for Paediatric Gastroenterology, Hepatology and Nutrition meeting, ESPGHAN, and it was in Leo, France. We presented at ESPGHAN the results of the liquid oral crofelemer, the formulation specifically for intestinal failure.
Lisa Conte: That, from a quality of life perspective, would allow the patient to receive most of their parenteral 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. Remember that number, 10% to 15%. This past June, we presented groundbreaking results at the 58th Annual, it is called the European Society for Paediatric Gastroenterology, Hepatology and Nutrition meeting, ESPGHAN, and it was in Leo, France. We presented at ESPGHAN the results of the liquid oral crofelemer, the formulation specifically for intestinal failure.
Speaker #1: 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 F scam .
Speaker #1: And it was in Lille , France . We presented it as scant . The results of the liquid oral crofelemer to the formulation , specifically for intestinal failure .
Speaker #1: 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.
Lisa Conte: It demonstrates 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 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 are 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 is hard to express how clinically relevant this is. As I mentioned, even a 10% reduction would have been considered clinically relevant.
Lisa Conte: It demonstrates 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 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 are 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 is hard to express how clinically relevant this is. As I mentioned, even a 10% reduction would have been considered clinically relevant.
Speaker #1: So basically, clean safety in one patient. The weekly parenteral support requirements, normalized to body weight, were reduced by up to 48%.
Speaker #1: Remember, the 10 to 15% I mentioned? We're talking about up to 48% following more than 12 months of therapy in the two SBS.
Speaker #1: If patients, the PS requirements normalized to body weight were reduced by up to 40%. Again, for over a year of treatment.
Speaker #1: 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.
Speaker #1: What was also really powerful is that after these patients were treated for about three months, they were, per protocol, taken off.
Lisa Conte: 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. These patients have now continued to be treated for over a year, and we expect they will 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 zero, the benefit exists into perpetuity.
Lisa Conte: 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. These patients have now continued to be treated for over a year, and we expect they will 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 zero, the benefit exists into perpetuity.
Speaker #1: 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 our product.
Speaker #1: So these patients have now continued to be treated for over a year . A year , and we expect they'll be on Crofelemer for the rest of their lives .
Speaker #1: 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 this is very consistent with the crofelemer that is in thousands of patients who have been in clinical trials for other disorders.
Speaker #1: As a reminder, drugs are approved by the FDA based on their benefit-risk ratio. When the risk is zero, the benefit exists into perpetuity.
Speaker #1: Now we have an additional MVID patient under compassionate use being treated with oral crofelemer under an FDA-authorized expanded access program, and safety and efficacy data regarding this infant was also presented at the same FDA meeting.
Lisa Conte: 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 infant was also presented at the same ESPGHAN meeting this June in Leo. 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. 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 a lethal natural history, this child is thriving.
Lisa Conte: 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 infant was also presented at the same ESPGHAN meeting this June in Leo. 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. 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 a lethal natural history, this child is thriving.
Speaker #1: This June, in Lille. And this is a fascinating situation where the patient was diagnosed with MDD right after birth, but was too young to enroll in the enrollment criteria imposed by the FDA on NAPA's clinical trial.
Speaker #1: 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 .
Speaker #1: 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.
Speaker #1: So in what was otherwise a catastrophic diagnosis with a 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 present for just the first year of life .
Lisa Conte: The patient has started to eat a little bit orally and is down to only 22 hours of parental support, or down from 22 hours on parental support, just the first year of life down to 18 hours. We are committed to providing our novel crofelemer formulation as an investigational drug as deemed medically necessary by the physician or caregiver for patients in these expanded access programs intended for mitigating the sequelae from MVID 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 intestinal failure due to MVID.
Lisa Conte: The patient has started to eat a little bit orally and is down to only 22 hours of parental support, or down from 22 hours on parental support, just the first year of life down to 18 hours. We are committed to providing our novel crofelemer formulation as an investigational drug as deemed medically necessary by the physician or caregiver for patients in these expanded access programs intended for mitigating the sequelae from MVID 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 intestinal failure due to MVID.
Speaker #1: Down , 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 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 .
Speaker #1: 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 .
Lisa Conte: 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. 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. After the blinded part is over, patients can continue in treatment-only extension if deemed relevant for the patients by a safety committee, of which we are not a member of, that remains blinded, as well as the treating physician, the family. Every single patient was deemed relevant to go into the treatment-only extension phase. The first MVID patients have entered the treatment-only extension.
Lisa Conte: 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. 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. After the blinded part is over, patients can continue in treatment-only extension if deemed relevant for the patients by a safety committee, of which we are not a member of, that remains blinded, as well as the treating physician, the family. Every single patient was deemed relevant to go into the treatment-only extension phase. The first MVID patients have entered the treatment-only extension.
Speaker #1: 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 .
Speaker #1: So after the blinded part is over, patients can continue in the treatment-only extension if deemed relevant for the patients by a safety committee, of which we are not a member.
Speaker #1: 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 , so the first ended patients have entered the treatment only extension .
Speaker #1: And with the patients from this treatment , only extension , the early patient access result patients that were presented , for example , at Eskom and the investigator initiated trial in UAE .
Lisa Conte: With the patients from this treatment-only extension, the early patient access result patients that were presented, for example, at ESPGHAN and the investigator-initiated trial in UAE, we are 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 are treating approximately 4% of the patient population. While it may sound bold that we are filing with a single-digit number of patients, it is relevant to other diseases given the percentage of the affected patients that we are treating. We are confident, and we are passionate to bring the benefit of crofelemer to approval for all MVID patients as expeditiously as possible.
Lisa Conte: With the patients from this treatment-only extension, the early patient access result patients that were presented, for example, at ESPGHAN and the investigator-initiated trial in UAE, we are 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 are treating approximately 4% of the patient population. While it may sound bold that we are filing with a single-digit number of patients, it is relevant to other diseases given the percentage of the affected patients that we are treating. We are confident, and we are passionate to bring the benefit of crofelemer to approval for all MVID patients as expeditiously as possible.
Speaker #1: 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.
Speaker #1: With essentially a single-digit number of patients, including the patients in our blinded trial and the patients in the expanded access and investigator-initiated trials.
Speaker #1: We estimate that we're treating approximately 4% of the patient population. So while it may sound bold that we're filing with a single-digit number of patients, it's relevant to other diseases.
Speaker #1: 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.
Speaker #1: 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 .
Lisa Conte: Regarding timeframe, we are 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 qualify to go into the treatment-only. Enough patients by Q4 of this year to file for breakthrough therapy designation in the United States. With breakthrough therapy designation, if it is 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 Q2, late in Q2 of 2027. With breakthrough designation, we could be approved in the US by the end of 2027 for MVID. Europe would be a bit later.
Lisa Conte: Regarding timeframe, we are 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 qualify to go into the treatment-only. Enough patients by Q4 of this year to file for breakthrough therapy designation in the United States. With breakthrough therapy designation, if it is 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 Q2, late in Q2 of 2027. With breakthrough designation, we could be approved in the US by the end of 2027 for MVID. Europe would be a bit later.
Speaker #1: So, enough patients by the fourth quarter of this year to file for Breakthrough Therapy designation in the United States, with Breakthrough Therapy designation.
Speaker #1: 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.
Speaker #1: Late in the second quarter of 2027. So, with breakthrough designation, we could be approved in the U.S. by the end of 2027.
Speaker #1: For Mvid, Europe would be a bit later. That would be in 2028, based on the European Medicines Agency and some of the requirements there.
Lisa Conte: 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 are unable to absorb the nutrients of life because they literally have a short bowel. There is not enough surface area. A normal intestine is about 20 to 25 feet. An SBS-IF intestine may be 5 feet or less. There is literally just not enough surface area. They too may end up on parenteral support up to 20 hours a day, 7 days a week. They have the same comorbidities, the same horrendous toxicities that you see with parenteral support in MVID patients.
Lisa Conte: 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 are unable to absorb the nutrients of life because they literally have a short bowel. There is not enough surface area. A normal intestine is about 20 to 25 feet. An SBS-IF intestine may be 5 feet or less. There is literally just not enough surface area. They too may end up on parenteral support up to 20 hours a day, 7 days a week. They have the same comorbidities, the same horrendous toxicities that you see with parenteral support in MVID patients.
Speaker #1: 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 .
Speaker #1: There's not enough surface area. A normal intestine is about 20 to 25 feet, and a size intestine may be five feet or less.
Speaker #1: So there's literally just not enough surface area. And they too may end up on parental support, up to 20 hours a day, seven days a week.
Speaker #1: And they have the same comorbidities , the same horrendous toxicities that you see with parental support in mbid patients . We have ongoing right now a phase two randomized , double blind , placebo controlled trial with the same formulation .
Lisa Conte: We have ongoing right now a phase II randomized double-blind placebo-controlled trial with the same formulation, the liquid formulation of crofelemer in adult SBS-IF patients. It is going on at various sites in Germany and Italy. This is still an orphan indication, and we do have orphan designation in the US and Europe for short bowel syndrome, just as we do for MVID in the US 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 a third of the patients, trauma accidents. Adults and pediatric SBS-IF patients face chronic dependence on parenteral support due, again, to their insufficient absorptive surface area in the intestines. In the United States, the population is about 12,500.
Lisa Conte: We have ongoing right now a phase II randomized double-blind placebo-controlled trial with the same formulation, the liquid formulation of crofelemer in adult SBS-IF patients. It is going on at various sites in Germany and Italy. This is still an orphan indication, and we do have orphan designation in the US and Europe for short bowel syndrome, just as we do for MVID in the US 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 a third of the patients, trauma accidents. Adults and pediatric SBS-IF patients face chronic dependence on parenteral support due, again, to their insufficient absorptive surface area in the intestines. In the United States, the population is about 12,500.
Speaker #1: The liquid formulation of crofelemer in adult SBS , I patients . And it's going on at various sites in Germany and Italy . This is still an orphan indication .
Speaker #1: And we do have orphan designation in the US and Europe for short bowel syndrome , just as we do for Mvid in the US and Europe , although it is a larger patient population than Mvid , which ended arises from congenital or abnormalities , SBS could be congenital abnormalities , abnormalities , surgical resection due to conditions like Crohn's disease , ischemia , surgical resection due to cancer , which is about a third of the patients trauma accidents , adult and pediatric sepsis patients face chronic dependence on parental support due again to their insufficient absorptive surface area in the intestines in the United States , the population is about 12,500 .
Speaker #1: 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 2 blinded study for SBS.
Lisa Conte: We are 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 steppingstone 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. In the competition world, there is nothing for MVID. There is nothing out there in development. There is nothing for these patients. In SBS, there is a product approved, and it is a GLP-2 approach, not GLP-1. That is the weight loss thing. GLP-2 is essentially a growth hormone.
Lisa Conte: We are 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 steppingstone 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. In the competition world, there is nothing for MVID. There is nothing out there in development. There is nothing for these patients. In SBS, there is a product approved, and it is a GLP-2 approach, not GLP-1. That is the weight loss thing. GLP-2 is essentially a growth hormone.
Speaker #1: Because our development program for MVID involves the same formulation, this plan provides a CMC—chemistry, manufacturing, and controls. Basically, it’s the manufacturing stepping stone to our planned pathway for ultimate approval of crofelemer for SBS.
Speaker #1: After Mvid, and it will be years after Mvid. But the safety would be the same. The manufacturing would be the same.
Speaker #1: So to in in the competition world , there's nothing for me . There's nothing out there in development . There's nothing for these patients in SBS , there is a product approved and it's a GLP two approach , not GLP one .
Speaker #1: That's the weight loss thing . GLP two is essentially a growth hormone . And what GLP two does is attempts to grow the intestine a bit .
Lisa Conte: What GLP-2 does is attempts to grow the intestine a bit so that parenteral support can be reduced by 10% to 15%. If you remember, those numbers are what is 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 is a growth hormone. You cannot use a growth hormone. For example, you do not want to encourage growth in cancer patients or anybody with a hyperproliferative abnormal situation, and that is about a third of the SBS patients. Nevertheless, what GLP-2 has done, it has established a business model and a regulatory approval benchmark. GLP-2s are reimbursed at about USD 0.5 million a year per patient in the United States.
Lisa Conte: What GLP-2 does is attempts to grow the intestine a bit so that parenteral support can be reduced by 10% to 15%. If you remember, those numbers are what is 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 is a growth hormone. You cannot use a growth hormone. For example, you do not want to encourage growth in cancer patients or anybody with a hyperproliferative abnormal situation, and that is about a third of the SBS patients. Nevertheless, what GLP-2 has done, it has established a business model and a regulatory approval benchmark. GLP-2s are reimbursed at about USD 0.5 million a year per patient in the United States.
Speaker #1: 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 the ID , GLP two growth hormone for SBS is not standard of care .
Speaker #1: 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 hyperproliferative abnormal situation .
Speaker #1: And that is about a third of the SBS patients . But nevertheless , when GLP two has done its established a business model and a regulatory approval benchmark , GLP two are reimbursed at about a half $1 million a year per patient in the United States .
Speaker #1: 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.
Lisa Conte: 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 cannot be used on a lifelong chronic basis, whereas crofelemer could. Crofelemer could even be used in conjunction with GLP-2s. 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 toxicities. What I have been talking about in our rare disease program, intestinal 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 transit times that would land in the toilet bowl.
Lisa Conte: 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 cannot be used on a lifelong chronic basis, whereas crofelemer could. Crofelemer could even be used in conjunction with GLP-2s. 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 toxicities. What I have been talking about in our rare disease program, intestinal 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 transit times that would land in the toilet bowl.
Speaker #1: They can't be used on a lifelong, chronic basis, whereas crofelemer could. Development could even be used in conjunction with GLP-2.
Speaker #1: So, crofelemer is really a paradigm-shifting opportunity to increase quality of life, potentially extend patients' lives, and have important physiological benefits and reduction of potential toxicities. So, what I've been talking about in our rare disease program, our testing failure program, is crofelemer. Crofelemer is the active ingredient in Mytesi.
Speaker #1: But our intestinal failure program is not Mytesi. It is a different formulation, a different product. Mytesi is a pill for intestinal failure.
Speaker #1: A pill would just go right through the patient . High throughput , high transit times . It would land in the toilet bowl .
Speaker #1: The oral liquid formulation , a highly concentrated lyophilized formulation of crofelemer , is non-growth hormone , and it's a drug candidate that would be used as adjunctive therapy to parental support through a first in class physiological mechanism of action , reducing liquid stool output and therefore reducing parental support needs .
Lisa Conte: The oral liquid formulation, a highly concentrated lyophilized formulation of crofelemer, is non-growth hormone, and it is a drug candidate that would be used as adjunctive therapy to parental support through a first-in-class physiological mechanism of action, reducing liquid stool output, and therefore reducing parental support needs and the associated toxicity associated with that. It is also important to note that crofelemer is defined as an antisecretory, first-in-class antisecretory drug. It is not an antidiarrheal. It is locally acting on intestinal chloride ion channel and normalization, reduces intestinal chloride-driven fluid accumulation. We are getting a bit technical here, but it results in reduction of the electrolyte and the fluid losses and the concordant parental support reductions, which is the clinically relevant endpoint in both MVID and short bowel syndrome intestinal failure.
Lisa Conte: The oral liquid formulation, a highly concentrated lyophilized formulation of crofelemer, is non-growth hormone, and it is a drug candidate that would be used as adjunctive therapy to parental support through a first-in-class physiological mechanism of action, reducing liquid stool output, and therefore reducing parental support needs and the associated toxicity associated with that. It is also important to note that crofelemer is defined as an antisecretory, first-in-class antisecretory drug. It is not an antidiarrheal. It is locally acting on intestinal chloride ion channel and normalization, reduces intestinal chloride-driven fluid accumulation. We are getting a bit technical here, but it results in reduction of the electrolyte and the fluid losses and the concordant parental support reductions, which is the clinically relevant endpoint in both MVID and short bowel syndrome intestinal failure.
Speaker #1: And the associated toxicity associated with with that It's also important to note that crofelemer is defined as an antisecretory first in class Antisecretory drug .
Speaker #1: It's not an Antidiarrheal , it's locally acting on intestinal chloride ion 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 fluid losses .
Speaker #1: And the concordant parental support reductions, which is the clinically relevant end in both MVID and short bowel syndrome, intestinal failure. We established our ability to perform and close an important non-dilutive business development deal in January with the Future Pact deal.
Lisa Conte: We 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 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. It is a profit center for us. We are a centralized manufacturer. 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 100 times larger than the HIV diarrhea market.
Lisa Conte: We 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 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. It is a profit center for us. We are a centralized manufacturer. 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 100 times larger than the HIV diarrhea market.
Speaker #1: 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 Pact .
Speaker #1: We continue to be the manufacturer of crofelemer for Mytesi and the Canalevia formulations for future path, and per the terms of the opportunity.
Speaker #1: 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.
Speaker #1: Future payments, again, non-dilutive. The intestinal failure market, that we are now sharply focused on, is considered to be approximately 100 times larger than the HIV diarrhea market.
Speaker #1: So with those numbers that I told you , basically $18 million upfront , 17 million additional milestones , we're talking about a market opportunity 100 times larger with the clinical proof of concept data .
Lisa Conte: With those numbers that I told you, basically $18 million upfront, $17 million additional milestones. We are talking about a market opportunity 100 times 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 zero, that we are providing to the patients with no alternative treatment. Briefly, I should mention, the major focus of our business is human health, of course, and our rare disease program is 100% of our human focus.
Lisa Conte: With those numbers that I told you, basically $18 million upfront, $17 million additional milestones. We are talking about a market opportunity 100 times 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 zero, that we are providing to the patients with no alternative treatment. Briefly, I should mention, the major focus of our business is human health, of course, and our rare disease program is 100% of our human focus.
Speaker #1: We have in hand . And the very near-term clinical and regulatory milestones ongoing , we're 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 .
Speaker #1: The serious unmet medical need, and driven first and foremost by the benefit and the benefit-risk, with risk being nearly zero, that we are providing to the patients with no alternative treatment.
Speaker #1: Just briefly, I should mention that a major focus of our business is human health, of course, and our rare disease program is 100% of our human focus.
Speaker #1: 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 NEO Norm Dog.
Lisa Conte: We do have a small business in animal health, and we are pleased to announce recently that we are planning for the anticipated commercial launch very shortly of a product called Neonorm Dog. It is a new extension of Jaguar’s non-prescription 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 is also an antisecretory mechanism of action. What we are 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.
Lisa Conte: We do have a small business in animal health, and we are pleased to announce recently that we are planning for the anticipated commercial launch very shortly of a product called Neonorm Dog. It is a new extension of Jaguar’s non-prescription 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 is also an antisecretory mechanism of action. What we are 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.
Speaker #1: It's a new extension of Jaguar's non prescription non neo norm franchise for companion animals . Neo Norm dog is designed to provide dog owners with access to a plant based non product intended to support normal stool consistency .
Speaker #1: GI fluid balance in dogs . It's an anti . Also an anti-secretory 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 can alleviate a one .
Speaker #1: Before it was licensed to Future Pack Can Alleviate One again, was our FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs?
Speaker #1: The Norm franchise currently includes other new Norms: non-prescription products for foals and for calves, as well as plant-based products to support proper hydration and bowel health in pre-weaned foals and calves.
Lisa Conte: The Neonorm franchise currently includes other Neonorm 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. 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.
Lisa Conte: The Neonorm franchise currently includes other Neonorm 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. 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.
Speaker #1: 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.
Speaker #1: And now with new norm doggy , we will have something to offer them into the doggy parents with easy availability of neo norm dogs through online and animal health retail channels , not just from their vet , including Amazon and Chewy , which is an absolute fantastic place for for animal health products .
Speaker #1: 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 Leezak.
Lisa Conte: With that description, you can hear that we are very excited, very enthused about what we are doing. I am going to hand the discussion over to Carol Lizak, now our CFO, for her recap of the financial highlights of Q2 2026. 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 is a much different impact on the sales and the revenue numbers that we are reporting. Carol, let me turn it over to you.
Lisa Conte: With that description, you can hear that we are very excited, very enthused about what we are doing. I am going to hand the discussion over to Carol Lizak, now our CFO, for her recap of the financial highlights of Q2 2026. 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 is a much different impact on the sales and the revenue numbers that we are reporting. Carol, let me turn it over to you.
Speaker #1: 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 my Tessie 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 pack .
Speaker #1: 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.
Speaker #2: 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.
Carol Lizak: Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I will begin my review of our financials for Q2 2026. License and grant revenue, as Lisa mentioned, Jaguar entered a US commercial licensing agreement with Future Pak in January 2026. Future Pak is now the exclusive US 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 Q1 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. Jaguar remains the manufacturer of crofelemer and Mytesi and supplies the product to Future Pak at cost-plus terms.
Carol Lizak: Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I will begin my review of our financials for Q2 2026. License and grant revenue, as Lisa mentioned, Jaguar entered a US commercial licensing agreement with Future Pak in January 2026. Future Pak is now the exclusive US 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 Q1 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. Jaguar remains the manufacturer of crofelemer and Mytesi and supplies the product to Future Pak at cost-plus terms.
Speaker #2: License and grant revenue . As Lisa mentioned , Jaguar entered a US commercial licensing agreement with Future Pack in January 2026 and Future Pack is now the exclusive US marketer for the company's Mytesi and can Olivia CA1 products license revenues for the initial 16 million upfront payment .
Speaker #2: In addition to the $3 million payment for early termination of the buyback option under this agreement, which was 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 Pack.
Speaker #2: Nappo remains the manufacturer of Crofelemer and Mytesi , and supplies the product to future pack 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 .
Carol Lizak: Additionally, the company recognized license fees of $43,000 in Q2 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of licensing fees were consistently recognized in each of the quarters of 2025 under this agreement. As of 30 June 2026, the total deferred revenue associated with this contract amounts to $468,000. Federal grant revenue recognized in Q2 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 is Mytesi, Gelclair, and Canalevia-CA1, was approximately $1.2 million in Q2 2026, which was comprised primarily of sales of Mytesi at cost plus to Future Pak.
Carol Lizak: Additionally, the company recognized license fees of $43,000 in Q2 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of licensing fees were consistently recognized in each of the quarters of 2025 under this agreement. As of 30 June 2026, the total deferred revenue associated with this contract amounts to $468,000. Federal grant revenue recognized in Q2 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 is Mytesi, Gelclair, and Canalevia-CA1, was approximately $1.2 million in Q2 2026, which was comprised primarily of sales of Mytesi at cost plus to Future Pak.
Speaker #2: Approximately 43,000 of license fees were consistently recognized in each of the quarters of 2025 . Under this agreement , as of June 30th , 2026 , the total deferred revenue associated with this contract amounts to $468,000 .
Speaker #2: Federal grant revenue recognized in the second quarter of 2026 for the clinical trial study related to the treatment of chemotherapy induced diarrhea or CED , in dogs , was $25,520 , a non last year for prescription product revenue , net , the total net revenue for the company's prescription products .
Speaker #2: That’s my Tessie. Gelclair and Olivia 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 Pack. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pack again.
Carol Lizak: In January 2026, 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 12 January 2026, are directed to Future Pak. Future Pak is privately held and does not report Mytesi sales. Compared to Q2 2025, the number of Mytesi bottles the company sold in Q2 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.
Carol Lizak: In January 2026, 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 12 January 2026, are directed to Future Pak. Future Pak is privately held and does not report Mytesi sales. Compared to Q2 2025, the number of Mytesi bottles the company sold in Q2 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.
Speaker #2: Under this agreement , all generated in the United States from Mytesi and cantilevered CA1 , effective from January 12th , 2026 , are directed to future pack .
Speaker #2: Future Pack 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.
Speaker #2: The decision to enter a commercial license agreement with Future Pack 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.
Speaker #2: 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.
Carol Lizak: The total net revenue for the company's prescription products in Q2 2026 represents a decrease of approximately 2% compared to Q1 2026, when total net revenue for prescription products was approximately $1.2 million. Additionally, prescription products net revenue decreased by 60% compared to Q2 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 30 June 2025, to a loss of $7.6 million in the quarter ended 30 June 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.
Carol Lizak: The total net revenue for the company's prescription products in Q2 2026 represents a decrease of approximately 2% compared to Q1 2026, when total net revenue for prescription products was approximately $1.2 million. Additionally, prescription products net revenue decreased by 60% compared to Q2 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 30 June 2025, to a loss of $7.6 million in the quarter ended 30 June 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.
Speaker #2: Additionally, prescription products net revenue decreased by 60% compared to the second quarter of 2025, when total revenues amounted to about $2.9 million.
Speaker #2: The loss from operations decreased , however , by about $400,000 , going from a loss of $8 million in the quarter ended June 30th , 2025 , to a loss of $7.6 million in the quarter ended June 30th , 2026 .
Speaker #2: 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 pack licensing agreement. For non-GAAP recurring EBITDA, for the second quarter of 2026 and 2025, there were net losses of about $8.4 million and $7.9 million, respectively.
Carol Lizak: For non-GAAP recurring EBITDA for Q2 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 30 June 2025, to a loss of $12.7 million in the quarter ended 30 June 2026. In addition to the loss from operations, interest expense increased by $176,000 from a $15,000 interest income for the quarter ended 30 June 2025, to about $161,000 in the quarter ended 30 June 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 30 June 2025, to a loss of $1.9 million in the quarter ended 30 June 2026.
Carol Lizak: For non-GAAP recurring EBITDA for Q2 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 30 June 2025, to a loss of $12.7 million in the quarter ended 30 June 2026. In addition to the loss from operations, interest expense increased by $176,000 from a $15,000 interest income for the quarter ended 30 June 2025, to about $161,000 in the quarter ended 30 June 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 30 June 2025, to a loss of $1.9 million in the quarter ended 30 June 2026.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Quarter ended June 30th , 2026 due to interest expenses accrued on notes . The fair value of financial and hybrid instrument 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 30th , 2026 , and again primarily due to fair value adjustments in liability .
Carol Lizak: And again, primarily due to fair value adjustments in liability classified warrants and notes payable designated as FVO. Loss and extinguishment of debt increased by $1.7 million from a loss of $1.8 million in the quarter ended 30 June 2025, to a loss of $3.5 million during the 3 months ended 30 June 2026, due to significant modifications to qualified for extinguishment accounting, with none recorded in the same period in 2025. Well, that concludes my recap of high-level financials for Q2 2026. I will now hand the discussion back to Lisa. Thank you.
Carol Lizak: And again, primarily due to fair value adjustments in liability classified warrants and notes payable designated as FVO. Loss and extinguishment of debt increased by $1.7 million from a loss of $1.8 million in the quarter ended 30 June 2025, to a loss of $3.5 million during the 3 months ended 30 June 2026, due to significant modifications to qualified for extinguishment accounting, with none recorded in the same period in 2025. Well, that concludes my recap of high-level financials for Q2 2026. I will now hand the discussion back to Lisa. Thank you.
Speaker #2: 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.
Speaker #2: Well, that concludes my recap of high-level financials for the second quarter of 2026. I will now hand the discussion back to Lisa.
Speaker #2: Thank you .
Speaker #1: 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 .
Lisa Conte: Thanks, Carol. We will 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 and 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 expensive IP patent strategy, just like any other pharmaceutical company, it is 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.
Lisa Conte: Thanks, Carol. We will 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 and 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 expensive IP patent strategy, just like any other pharmaceutical company, it is 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.
Speaker #1: Importantly, Crofelemer's status as the first and only oral prescription drug approved by the FDA under botanical guidance functions as a de facto and perpetual IP intestinal protection shield—an exclusivity shield.
Speaker #1: As there is no practical pathway to bring a generic to market . So even though we have a very robust and expensive IP patent strategy , just like any other pharmaceutical company is sort of the price of being in the business , we do have approximately 185 issued patents .
Speaker #1: We essentially have exclusivity perpetually to infinity and beyond , which is very powerful when terminal value calculations with , for example , potential commercial partners .
Speaker #1: 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 .
Lisa Conte: You do not have that patent cliff that you often hear about and read about with other companies. As you can probably tell, all members of the Jaguar, 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 businesses 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 will see you the next quarter.
Lisa Conte: You do not have that patent cliff that you often hear about and read about with other companies. As you can probably tell, all members of the Jaguar, 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 businesses 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 will see you the next quarter.
Speaker #1: 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.
Speaker #1: Everything we do at Jaguar , Napo and Napa Therapeutics is rewarding , and our efforts to address such truly devastating , rare intestinal failure diseases has really provided satisfaction on on another level , this concludes our webcast for today .
Speaker #1: Thank you very much for joining, and we'll see you in the next quarter.
Operator: This concludes today's conference. We thank you again for your participation. You may disconnect your lines at this time.
Operator: This concludes today's conference. We thank you again for your participation. You may disconnect your lines at this time.
