Latest news with #SBS-IF
USA Today
30-06-2025
- Business
- USA Today
Proof-of-Concept Results Show Jaguar Health's Crofelemer Reduced Total Parenteral Nutrition in Third Intestinal Failure Orphan Disease Patient
As recently announced, initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5% The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period intended to last 30 days, per the study protocol, but were promptly placed back on daily crofelemer treatment because their symptoms worsened Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's intestinal failure products, resulting in non-dilutive funding for Jaguar Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that initial proof-of-concept results show that a novel liquid formulation of crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in a third intestinal failure patient. This is the second pediatric patient with intestinal failure due to the orphan disease short bowel syndrome (SBS-IF) who was treated with crofelemer. To date, three patients with intestinal failure due to SBS-IF or microvillus inclusion disease (MVID) have been treated with crofelemer in this exploratory, single-arm open label non-randomized IIT in Abu Dhabi. As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, initial proof-of-concept results from this study show that crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, reduced the required TPN and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, this data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output – an indicator of improved nutrient oral absorption. 'We're very pleased to report that the second pediatric SBS-IF patient participating in this IIT exhibited a similar response for TPN reduction, further exemplifying that crofelemer's paradigm-shifting antisecretory mechanism of action may have the potential to provide a novel therapeutic option to modify disease progression due to the reductions in TPN and associated comorbidities in MVID and SBS-IF patients and improve their quality of life,' said Lisa Conte, Jaguar's Founder and CEO. 'This SBS-IF patient was administered the highest dose of crofelemer provided for in the approved protocol for the IIT, with no resulting safety issues.' Per the IIT protocol, as announced, the initial pediatric MVID patient participating in the study was taken off crofelemer after 12 weeks of treatment for an intended period of 30 days. However, after just 8 days, the patient's parents requested reinitiation of crofelemer dosing, as the patient's symptoms worsened – evidenced by increased stool output and decreased urine output – and the patient was restarted on daily treatment with crofelemer. The initial pediatric SBS-IF patient participating in the study also had crofelemer withdrawn per the protocol after 12 weeks. This patient then exhibited a relapse of symptoms and was put back on daily treatment with crofelemer, and has since been maintaining a significant TPN reduction. Jaguar plans to continue supplying crofelemer to Dr. Mohamad Miqdady, the principal investigator for this IIT, for the patients participating in this study for as long as Dr. Miqdady feels is medically necessary. Dr. Miqdady has submitted initial proof-of-concept data from the ongoing IIT in Abu Dhabi for all three above-referenced patients to a major international pediatric gastroenterological conference for consideration for presentation. Jaguar, through Jaguar family companies Napo and Napo Therapeutics, is currently supporting two independent proof-of-concept IITs, and conducting two placebo-controlled Phase 2 studies, of crofelemer in patients with intestinal failure due to MVID and SBS-IF in the United States, European Union, and/or Middle East/North Africa regions. Completion of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients is expected in mid-2026 as planned. 'Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products – with the goal of generating non-dilutive funding for Jaguar,' said Conte. 'Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the ongoing IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval.' Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer's paradigm-shifting antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in patients with intestinal failure due to MVID and short bowel syndrome. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN. The initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) PRIME program that may accelerate regulatory approval pathways in the EU for this indication. This data may also support qualification of crofelemer for the FDA's Breakthrough Therapy program for expedited regulatory approval in the US. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions. The IIT in Abu Dhabi is being conducted by Dr. Miqdady at Sheikh Khalifa Medical City (SKMC), a flagship tertiary hospital in the United Arab Emirates and the largest teaching medical center in Abu Dhabi. Dr. Miqdady, a recognized leader in pediatric gastroenterology, serves as the Chief of Pediatric Gastroenterology, Hepatology and Nutrition at SKMC. He is an American board-certified pediatric GI, hepatology and nutrition professor at Khalifa University in Abu Dhabi, and also serves as a member of Napo's Scientific Advisory Board. Dr. Miqdady completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as 'dragon's blood,' of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative(ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that completion of Napo's Phase 2 study of crofelemer in pediatric MVID patients will occur mid-2026, Jaguar's expectation that its strategy of seeking business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products may support generation of non-dilutive funding for Jaguar, Jaguar's expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval of crofelemer for MVID, Jaguar's expectation that crofelemer's mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar's expectation that proof-of-concept data in MVID may support crofelemer's potential inclusion in the EMA's PRIME program for expediated and assisted regulatory approval and in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar's expectation that additional proof-of-concept results from IITs will be available throughout 2025, and Jaguar's expectation that published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for MVID and SBS-IF. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire
Indianapolis Star
23-06-2025
- Business
- Indianapolis Star
Jaguar Health Provides Updates on Orphan Disease Intestinal Failure Development Program for Crofelemer
Enrollment in company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25% As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short bowel syndrome by up to 27% and 12.5% respectively; data from the third patient enrolled is expected Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's intestinal failure products, resulting in non-dilutive funding for Jaguar SAN FRANCISCO, CA / ACCESS Newswire / June 23, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today provided updates on the company's orphan disease intestinal failure program. Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting two independent proof-of-concept investigator-initiated trials (IITs), and conducting two placebo-controlled Phase 2 studies, of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, in patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) in the United States, European Union, and/or Middle East/North Africa regions. As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, initial proof-of-concept results from the ongoing exploratory, single-arm open label non-randomized IIT of crofelemer in Abu Dhabi in pediatric intestinal failure patients show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, this data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output – an indicator of improved nutrient oral absorption. Data from the third patient enrolled in the IIT is expected. Completion of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients is expected in mid-2026 as planned. 'Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products – with the goal of generating non-dilutive funding for Jaguar,' said Lisa Conte, Jaguar's Founder and CEO. 'I attended the BIO International Convention in Boston last week and took part in productive meetings at the event.' 'Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the ongoing IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval,' said Conte. 'We're excited to report that enrollment in the company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients is at approximately 25% and patient screening is continuing. For the company's placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for SBS-IF in adults, enrollment is above 10%, and patient screening is continuing,' said Conte. 'Additionally, enrollment is continuing in the two ongoing proof-of-concept IITs. These are important milestones in development efforts for crofelemer for the treatment and management of intestinal failure related to these devastating orphan diseases and will continue to generate IIT data.' Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer's paradigm-shifting antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in patients with intestinal failure due to MVID and short bowel syndrome. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN. The initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) PRIME program that may accelerate regulatory approval pathways in the EU. This data may also support qualification of crofelemer for the FDA's Breakthrough Therapy program for expedited regulatory approval in the US. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as 'dragon's blood,' of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that completion of Napo's Phase 2 study of crofelemer in pediatric MVID patients will occur mid-2026, Jaguar's expectation that the two ongoing proof-of-concept IITs will continue to generate data, Jaguar's expectation that data from the third patient enrolled in the IIT in Abu Dhabi is expected, Jaguar's expectation that its strategy of seeking business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products may support generation of non-dilutive funding for Jaguar, Jaguar's expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval of crofelemer for MVID, Jaguar's expectation that crofelemer's mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar's expectation that proof-of-concept data in MVID may support crofelemer's potential inclusion in the EMA's PRIME program for expediated and assisted regulatory approval and in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar's expectation that additional proof-of-concept results from IITs will be available throughout 2025, and Jaguar's expectation that published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for MVID and SBS-IF. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.
Miami Herald
23-06-2025
- Business
- Miami Herald
Jaguar Health Provides Updates on Orphan Disease Intestinal Failure Development Program for Crofelemer
Enrollment in company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25% As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short bowel syndrome by up to 27% and 12.5% respectively; data from the third patient enrolled is expected Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's intestinal failure products, resulting in non-dilutive funding for Jaguar SAN FRANCISCO, CA / ACCESS Newswire / June 23, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) today provided updates on the company's orphan disease intestinal failure program. Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting two independent proof-of-concept investigator-initiated trials (IITs), and conducting two placebo-controlled Phase 2 studies, of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, in patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) in the United States, European Union, and/or Middle East/North Africa regions. As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, initial proof-of-concept results from the ongoing exploratory, single-arm open label non-randomized IIT of crofelemer in Abu Dhabi in pediatric intestinal failure patients show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, this data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output - an indicator of improved nutrient oral absorption. Data from the third patient enrolled in the IIT is expected. Completion of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients is expected in mid-2026 as planned. "Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products - with the goal of generating non-dilutive funding for Jaguar," said Lisa Conte, Jaguar's Founder and CEO. "I attended the BIO International Convention in Boston last week and took part in productive meetings at the event." "Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the ongoing IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval," said Conte. "We're excited to report that enrollment in the company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients is at approximately 25% and patient screening is continuing. For the company's placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for SBS-IF in adults, enrollment is above 10%, and patient screening is continuing," said Conte. "Additionally, enrollment is continuing in the two ongoing proof-of-concept IITs. These are important milestones in development efforts for crofelemer for the treatment and management of intestinal failure related to these devastating orphan diseases and will continue to generate IIT data." Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer's paradigm-shifting antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in patients with intestinal failure due to MVID and short bowel syndrome. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN. The initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) PRIMEprogram that may accelerate regulatory approval pathways in the EU. This data may also support qualification of crofelemer for the FDA's Breakthrough Therapyprogram for expedited regulatory approval in the US. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions. About CrofelemerCrofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative(ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about:Jaguar Health, visit Pharmaceuticals, visit Therapeutics, visit Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that completion of Napo's Phase 2 study of crofelemer in pediatric MVID patients will occur mid-2026, Jaguar's expectation that the two ongoing proof-of-concept IITs will continue to generate data, Jaguar's expectation that data from the third patient enrolled in the IIT in Abu Dhabi is expected, Jaguar's expectation that its strategy of seeking business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products may support generation of non-dilutive funding for Jaguar, Jaguar's expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval of crofelemer for MVID, Jaguar's expectation that crofelemer's mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar's expectation that proof-of-concept data in MVID may support crofelemer's potential inclusion in the EMA's PRIME program for expediated and assisted regulatory approval and in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar's expectation that additional proof-of-concept results from IITs will be available throughout 2025, and Jaguar's expectation that published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for MVID and SBS-IF. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact:hello@ SOURCE: Jaguar Health, Inc.
Miami Herald
16-05-2025
- Business
- Miami Herald
Jaguar Health Reports First Quarter 2025 Financials
The combined net Q1 2025 revenue of approximately $2.2 million for prescription and non-prescription products, including license revenue, decreased approximately 6% versus net Q1 2024 revenue of $2.4 million and 37% versus net Q4 2024 revenue of $3.5 million Mytesi prescription volume increased by approximately 1.8% in Q1 2025 over Q1 2024 and decreased by approximately 13.5% in Q1 2025 over Q4 2024 REMINDER: Today Jaguar to host investor webcast at 4:15 p.m. Eastern regarding Q1 2025 financials and company updates; Click here to register Proof-of-concept (POC) results show crofelemer reduced total parenteral nutrition in patients with rare orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) by up to 27% and 12.5% - potential to modify disease progression in intestinal failure patients; Click here to access replay of April 30, 2025 investor webcast about results; additional POC results expected throughout 2025 for MVID and SBS-IF FDA meeting in Q2 2025 on statistically significant results of Phase 3 OnTarget trial of crofelemer in prespecified subgroup of patients with breast cancer SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / May 15, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated first-quarter 2025 financial results. 2025 FIRST QUARTER COMPANY FINANCIAL RESULTS: Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the first quarters of 2025 and 2024. Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the first quarters of 2025 and 2024 were a net loss of $9.6 million and $7.5 million, respectively. Note Regarding Use of Non-GAAP Measures The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and 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. The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition. Participation Instructions for WebcastWhen: Thursday, May 15, 2025 at 4:15 p.m. EasternParticipant Registration & Access Link: Click Here Replay Instructions for WebcastReplay of the webcast on the investor relations section of Jaguar's website: (click here) About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram About Mytesi® Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. About Gelclair® INDICATIONS GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers. IMPORTANT SAFETY INFORMATION Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the GELCLAIR is swallowed accidentally, no adverse effects are no improvement is seen within 7 days, a physician should be consulted. You are encouraged to report negative side effects of prescription medical products to the FDA. Visit call 1-855-273-0468 or fill-in the form at this link. Please see full Prescribing Information at: Important Safety Information About Canalevia®-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer has the potential to modify disease progression in patients with intestinal failure due to MVID or short bowel syndrome, Jaguar's expectation that the Company will meet with the U.S. Food and Drug Administration (FDA) in the second quarter of 2025 regarding the statistically significant results of the OnTarget trial in the prespecified subgroup of patients with breast cancer, Jaguar's expectation that it will host an investor webcast on May 15, 2025, and the Company's expectation that additional POC results may be available throughout 2025. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ SOURCE: Jaguar Health, Inc.
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15-05-2025
- Business
- Yahoo
Jaguar Health Reports First Quarter 2025 Financials
The combined net Q1 2025 revenue of approximately $2.2 million for prescription and non-prescription products, including license revenue, decreased approximately 6% versus net Q1 2024 revenue of $2.4 million and 37% versus net Q4 2024 revenue of $3.5 million Mytesi prescription volume increased by approximately 1.8% in Q1 2025 over Q1 2024 and decreased by approximately 13.5% in Q1 2025 over Q4 2024 REMINDER: Today Jaguar to host investor webcast at 4:15 p.m. Eastern regarding Q1 2025 financials and company updates; Click here to register Proof-of-concept (POC) results show crofelemer reduced total parenteral nutrition in patients with rare orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) by up to 27% and 12.5% - potential to modify disease progression in intestinal failure patients; Click here to access replay of April 30, 2025 investor webcast about results; additional POC results expected throughout 2025 for MVID and SBS-IF FDA meeting in Q2 2025 on statistically significant results of Phase 3 OnTarget trial of crofelemer in prespecified subgroup of patients with breast cancer SAN FRANCISCO, CALIFORNIA / / May 15, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated first-quarter 2025 financial results. 2025 FIRST QUARTER COMPANY FINANCIAL RESULTS: Net Prescription Products Revenue: The combined net revenue for the Company's prescription products (Mytesi®, Gelclair®, and Canalevia®-CA1) was approximately $2.2 million in the first quarter of 2025, representing a decrease of approximately 37% over the combined net revenue in the fourth quarter of 2024, which totaled approximately $3.5 million, and a decrease of approximately 6% over the combined net revenue for the first quarter of 2024, which totaled approximately $2.4 million. Mytesi Prescription Volume: Mytesi prescription volume increased by approximately 1.8% in the first quarter of 2025 over the first quarter of 2024 and decreased by approximately 13.5% in the first quarter of 2025 over the fourth quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. License Revenue: For the first quarter of 2025, the Company recognized license fees of $42,500 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. This amount was consistently recorded in the fourth quarter of 2024 and none in the first quarter of 2024. As of March 31, 2025, the total deferred revenue associated with this contract amounts to approximately $0.7 million. Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the first quarters of 2025 and 2024. Three Months Ending Financial Highlights March 31, (in thousands, except per share amounts) 2025 2024 $ change % change Net product revenue $ 2,214 $ 2,351 (137 ) -6 % Loss from operations $ (9,421 ) $ (8,215 ) (1,206 ) 15 % Net loss attributable to common stockholders $ (10,465 ) $ (9,226 ) (1,239 ) 13 % Net loss per share, basic and diluted $ (16.70 ) $ (87.12 ) 70 -81 % Cost of Product Revenue: Total cost of product revenue increased by approximately $0.1 million, from $0.4 million for the quarter ended March 31, 2024 compared to $0.5 million for the quarter ended March 31, 2025. Research and Development: The R&D expense decreased by $0.6 million, from $4.3 million for the quarter ended March 31, 2024 compared to $3.7 million for the quarter ended March 31, 2025, primarily due to the conclusion of the Phase 3 OnTarget clinical trial, which reduced trial-related contract manufacturing services and regulatory activities. Sales and Marketing: The Sales and Marketing expense increased by approximately $1.1 million, from $1.4 million for the quarter ended March 31, 2024 to $2.5 million during the same quarter in 2025. The increase in this expense was mostly due to expanded market access activities and the commercial launch of Gelclair. General and Administrative: The G&A expense increased by approximately $0.5 million, from $4.4 million for the quarter ended March 31, 2024 to $4.9 million during the same quarter in 2025, largely due to increased legal expenses. Loss from Operations: Loss from operations increased by $1.2 million, from $8.2 million in the quarter ended March 31, 2024 to $9.4 million during the same period in 2025. Net Loss: Net loss attributable to common shareholders increased by approximately $1.2 million, from $9.2 million in the quarter ended March 31, 2024 to $10.4 million in the same period in 2025. In addition to the loss from operations: Interest expense decreased by approximately $0.7 million, from $0.6 million for the quarter ended March 31, 2024, to approximately $56,000 income for the same period in 2025, primarily due to changing the accounting of certain debt instruments designated at Fair Value Option (FVO). Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the first quarters of 2025 and 2024 were a net loss of $9.6 million and $7.5 million, respectively. Three Months Ending March 31, (in thousands) 2025 2024 $ change % change (unaudited) Net loss attributable to common stockholders $ (10,465 ) $ (9,226 ) 1,239 -13 % Adjustments: Interest expense (56 ) 611 667 109 % Property and equipment depreciation 17 17 - 0 % Amortization of intangible assets 463 484 21 4 % Share-based compensation expense 301 581 280 48 % Income taxes - - Non-GAAP EBITDA (9,740 ) (7,533 ) 2,207 -29 % Gain on extinguishment of debt (1,245 ) (1,245 ) 100 % Non-GAAP Recurring EBITDA $ (9,740 ) $ (8,778 ) 962 -11 % Note Regarding Use of Non-GAAP Measures The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and 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. The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition. Participation Instructions for WebcastWhen: Thursday, May 15, 2025 at 4:15 p.m. EasternParticipant Registration & Access Link: Click Here Replay Instructions for WebcastReplay of the webcast on the investor relations section of Jaguar's website: (click here) About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram About Mytesi® Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. About Gelclair® INDICATIONS GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers. IMPORTANT SAFETY INFORMATION Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients. No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth. If GELCLAIR is swallowed accidentally, no adverse effects are anticipated. If no improvement is seen within 7 days, a physician should be consulted. You are encouraged to report negative side effects of prescription medical products to the FDA. Visit call 1-855-273-0468 or fill-in the form at this link. Please see full Prescribing Information at: Important Safety Information About Canalevia®-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer has the potential to modify disease progression in patients with intestinal failure due to MVID or short bowel syndrome, Jaguar's expectation that the Company will meet with the U.S. Food and Drug Administration (FDA) in the second quarter of 2025 regarding the statistically significant results of the OnTarget trial in the prespecified subgroup of patients with breast cancer, Jaguar's expectation that it will host an investor webcast on May 15, 2025, and the Company's expectation that additional POC results may be available throughout 2025. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire
