Latest news with #MVID
Miami Herald
20-05-2025
- Business
- Miami Herald
First Patient Randomized in Jaguar Health's Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Crofelemer in Pediatric Patients with Microvillus Inclusion Disease (MVID)
As announced, initial proof-of-concept (POC) results from distinct ongoing investigator-initiated trial (IIT) in Abu Dhabi show crofelemer reduced total parenteral support in a pediatric MVID patient with intestinal failure by up to 27%; per the IIT protocol, patient was taken off crofelemer after 12 weeks of treatment for a period of 30 days, but was restarted on daily crofelemer treatment after just 8 days, as patient's symptoms were worsening Additional POC IIT results expected throughout 2025 for MVID; results from company's MVID Phase 2 study expected with completion of treatment in H2 2026 Ground-breaking results in single-digit number of MVID patients could potentially lead to expedited approval in the EU through PRIME and to Breakthrough Therapy designation in the US SAN FRANCISCO, CA / ACCESS Newswire / May 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. today announced that the first patient has been randomized in Napo's randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the safety and efficacy of the novel crofelemer oral powder for solution formulation in pediatric patients with intestinal failure due to the ultrarare disease MVID. Patients with MVID suffer from devastating diarrhea and dehydration caused by this debilitating, lifelong condition. These pediatric patients often require lifelong and life-sustaining total parenteral nutrition (TPN) with additional supplemental intravenous (IV) fluids, termed total parenteral support, which is the standard of care for MVID, for up to 7 days a week greater than 50% of the time each day to provide adequate nutrient and electrolyte support. While crucial for MVID patients, TPN carries a significant risk of morbidity and mortality due to infections, metabolic complications, liver and/or kidney disease, and a risk of neurodevelopmental delay. There are currently no approved drug treatments for MVID. As previously announced, and as presented last month at the 11th Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates, the initial proof-of-concept results from the ongoing and independent proof-of-concept investigator-initiated trial (IIT) at Sheikh Khalifa Medical City (SKMC) showed that crofelemer reduced the required TPN and/or supplementary intravenous fluids - collectively referred to as parenteral support - in the first participating MVID patient by up to 27% at the end of 12-weeks of crofelemer treatment. 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. Per the protocol for the IIT at SKMC, the pediatric MVID patient was taken off crofelemer after 12 weeks of treatment for a period of 30 days. After just 8 days, the patient's parents requested reinitiation of crofelemer dosing, as the patient's symptoms were worsening - evidenced by increased stool output and decreased urine output. Hence, the patient was restarted on daily treatment with crofelemer. "We're very happy that the first patient has been randomized in Napo's randomized, double-blind placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID patients," said Lisa Conte, Jaguar's founder, president, and CEO. "This is another important milestone in development efforts for crofelemer for the treatment and management of intestinal failure related to this devastating ultrarare pediatric disease. For this study, randomization represents the key milestone of assigning a participating patient to either the crofelemer or placebo treatment group in a double-blind, placebo-controlled within-patient crossover study." "Additional proof-of-concept results for MVID from the ongoing IIT of crofelemer at SKMC in pediatric patients with intestinal failure due to MVID and other disorders are expected throughout 2025," Conte said. "The results of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients are expected to be available in the second half of 2026. Because the IIT of crofelemer for MVID is an unblinded, open-label study, results from this IIT are expected to be available sooner." Based on the initial proof-of-concept findings presented last month at the 11th Annual ELITE PED-GI Congress, crofelemer's novel antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to modify the disease progression associated with intestinal failure due to MVID in pediatric patients, as evidenced by the reductions in total parenteral support and potential to improve the quality of life of MVID patients. "Based on preliminary communications with European Medicines Agency (EMA) regulatory members that focus on PRIME (Priority Medicines), a program that provides enhanced interactions and early dialogue for development of novel medicines targeting unmet medical needs, we are excited by the initial findings from the IIT being conducted at SKMC," said Conte. "We are not aware of any other intervention that has shown the ability to reduce the required administration of life-sustaining parenteral support including TPN, thus potentially improving nutrient absorption in patients with MVID. Given the ultrarare nature of MVID, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval in the European Union. Crofelemer may qualify for participation in PRIME in the European Union for MVID and potentially in the U.S. Food and Drug Administration's (FDA) Breakthrough Therapy program for this ultrarare pediatric indication. Additionally, in accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID could support reimbursed early patient access to crofelemer for this debilitating condition." 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 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 Pharmaceuticals, visit Therapeutics, visit 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 additional POC results for MVID from the IIT in pediatric patients with intestinal failure due to MVID and other disorders may be available throughout 2025, Jaguar's expectation that results from the company's MVID Phase 2 study will be available with completion of treatment in H2 2026, Jaguar's expectation that crofelemer's novel antisecretory mechanism of action may have the potential to provide a novel therapeutic option to modify the disease progression associated with intestinal failure due to MVID in pediatric patients and the potential to improve the quality of life of MVID patients, Jaguar's expectation that, given the ultrarare nature of MVID, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval in the Europe Union, Jaguar's expectation that crofelemer may qualify for participation in PRIME in the European Union for MVID and potentially in the FDA's Breakthrough Therapyprogram, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID could support reimbursed early patient access to crofelemer for this debilitating condition. 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.
Associated Press
20-05-2025
- Business
- Associated Press
First Patient Randomized in Jaguar Health's Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Crofelemer in Pediatric Patients with Microvillus Inclusion Disease (MVID)
As announced, initial proof-of-concept (POC) results from distinct ongoing investigator-initiated trial (IIT) in Abu Dhabi show crofelemer reduced total parenteral support in a pediatric MVID patient with intestinal failure by up to 27%; per the IIT protocol, patient was taken off crofelemer after 12 weeks of treatment for a period of 30 days, but was restarted on daily crofelemer treatment after just 8 days, as patient's symptoms were worsening Additional POC IIT results expected throughout 2025 for MVID; results from company's MVID Phase 2 study expected with completion of treatment in H2 2026 Ground-breaking results in single-digit number of MVID patients could potentially lead to expedited approval in the EU through PRIME and to Breakthrough Therapy designation in the US SAN FRANCISCO, CA / ACCESS Newswire / May 20, 2025 / Jaguar Health, Inc. ( NASDAQ:JAGX ) (Jaguar) family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. today announced that the first patient has been randomized in Napo's randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the safety and efficacy of the novel crofelemer oral powder for solution formulation in pediatric patients with intestinal failure due to the ultrarare disease MVID. Patients with MVID suffer from devastating diarrhea and dehydration caused by this debilitating, lifelong condition. These pediatric patients often require lifelong and life-sustaining total parenteral nutrition (TPN) with additional supplemental intravenous (IV) fluids, termed total parenteral support, which is the standard of care for MVID, for up to 7 days a week greater than 50% of the time each day to provide adequate nutrient and electrolyte support. While crucial for MVID patients, TPN carries a significant risk of morbidity and mortality due to infections, metabolic complications, liver and/or kidney disease, and a risk of neurodevelopmental delay. There are currently no approved drug treatments for MVID. As previously announced, and as presented last month at the 11th Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates, the initial proof-of-concept results from the ongoing and independent proof-of-concept investigator-initiated trial (IIT) at Sheikh Khalifa Medical City (SKMC) showed that crofelemer reduced the required TPN and/or supplementary intravenous fluids - collectively referred to as parenteral support - in the first participating MVID patient by up to 27% at the end of 12-weeks of crofelemer treatment. 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. Per the protocol for the IIT at SKMC, the pediatric MVID patient was taken off crofelemer after 12 weeks of treatment for a period of 30 days. After just 8 days, the patient's parents requested reinitiation of crofelemer dosing, as the patient's symptoms were worsening - evidenced by increased stool output and decreased urine output. Hence, the patient was restarted on daily treatment with crofelemer. 'We're very happy that the first patient has been randomized in Napo's randomized, double-blind placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID patients,' said Lisa Conte, Jaguar's founder, president, and CEO. 'This is another important milestone in development efforts for crofelemer for the treatment and management of intestinal failure related to this devastating ultrarare pediatric disease. For this study, randomization represents the key milestone of assigning a participating patient to either the crofelemer or placebo treatment group in a double-blind, placebo-controlled within-patient crossover study.' 'Additional proof-of-concept results for MVID from the ongoing IIT of crofelemer at SKMC in pediatric patients with intestinal failure due to MVID and other disorders are expected throughout 2025,' Conte said. 'The results of Napo's randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients are expected to be available in the second half of 2026. Because the IIT of crofelemer for MVID is an unblinded, open-label study, results from this IIT are expected to be available sooner.' Based on the initial proof-of-concept findings presented last month at the 11th Annual ELITE PED-GI Congress, crofelemer's novel antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to modify the disease progression associated with intestinal failure due to MVID in pediatric patients, as evidenced by the reductions in total parenteral support and potential to improve the quality of life of MVID patients. 'Based on preliminary communications with European Medicines Agency (EMA) regulatory members that focus on PRIME (Priority Medicines), a program that provides enhanced interactions and early dialogue for development of novel medicines targeting unmet medical needs, we are excited by the initial findings from the IIT being conducted at SKMC,' said Conte. 'We are not aware of any other intervention that has shown the ability to reduce the required administration of life-sustaining parenteral support including TPN, thus potentially improving nutrient absorption in patients with MVID. Given the ultrarare nature of MVID, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval in the European Union. Crofelemer may qualify for participation in PRIME in the European Union for MVID and potentially in the U.S. Food and Drug Administration's (FDA) Breakthrough Therapy program for this ultrarare pediatric indication. Additionally, in accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID could support reimbursed early patient access to crofelemer for this debilitating condition.' 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 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 Forward-Looking Statements Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that additional POC results for MVID from the IIT in pediatric patients with intestinal failure due to MVID and other disorders may be available throughout 2025, Jaguar's expectation that results from the company's MVID Phase 2 study will be available with completion of treatment in H2 2026, Jaguar's expectation that crofelemer's novel antisecretory mechanism of action may have the potential to provide a novel therapeutic option to modify the disease progression associated with intestinal failure due to MVID in pediatric patients and the potential to improve the quality of life of MVID patients, Jaguar's expectation that, given the ultrarare nature of MVID, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval in the Europe Union, Jaguar's expectation that crofelemer may qualify for participation in PRIME in the European Union for MVID and potentially in the FDA's Breakthrough Therapyprogram, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID could support reimbursed early patient access to crofelemer for this debilitating condition. 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: [email protected] Jaguar-JAGX SOURCE: Jaguar Health, Inc. press release
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.
Yahoo
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
Miami Herald
07-05-2025
- Business
- Miami Herald
Jaguar Health Provides Overview of 2025 Crofelemer-Related Catalysts
Press Releases Jaguar Health Provides Overview of 2025 Crofelemer-Related Catalysts Crofelemer is the only oral drug approved by the FDA's Center for Drug Evaluation and Research under Botanical Guidance Click here to access replay of company's April 30, 2025 investor webcast Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today provided an overview of expected Q2 - Q4 2025 catalysts related to potential follow-on indications for crofelemer, the company's novel plant-based prescription drug approved by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). "As discussed during Jaguar's investor webcast last week, 2025 is a year of catalysts for crofelemer in both of our major development programs - our rare disease intestinal failure program and our cancer therapy-related diarrhea program," said Lisa Conte, Jaguar's Founder and CEO. "As a reminder, crofelemer is the only oral drug approved under the FDA's Botanical Guidance. It is not a biologic product. Click here to access the replay of our April 30, 2025 investor webcast." Rare Disease Intestinal Failure Program Initial proof-of-concept (POC) results were issued last week for the ongoing investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer in Abu Dhabi in the United Arab Emirates in pediatric patients with intestinal failure due to the rare orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). The initial POC results, presented April 26, 2025 at the Annual ELITE PED-GI Congress, show crofelemer reduced the required total parenteral nutrition (TPN) and/or supplementary intravenous fluids, collectively referred to as parenteral support, in patients with intestinal failure due to MVID and SBS-IF by up to 27% and 12.5% respectively Crofelemer also reduced stool volume output, frequency of watery stools, and increased urine output - indicating improved nutrient oral absorption Based on these initial findings, crofelemer's novel 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 this patient population The observed 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 This initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) PRIME program for expediated and assisted regulatory approval in the EU as well as in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting three POC IITs, and conducting two placebo-controlled Phase 2 studies, for crofelemer for MVID and/or SBS-IF patients in the US, EU, and/or Middle East/North Africa regions Additional POC results from IITs in MVID and/or SBS-IF are expected throughout 2025 Cancer Therapy-Related Diarrhea (CTD) Program As announced, the FDA granted Napo a Type C Meeting in Q2 2025 to discuss the responder analysis results in the prespecified subgroup of patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial of crofelemer for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy. While the initial top line results from the OnTarget study showed that this multicenter, double-blind, placebo-controlled pivotal trial did not meet its primary endpoint for the prespecified analysis of all tumor types, the subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup. The company's goal for the meeting is to discuss the most efficient potential pathway to make crofelemer available to adult breast cancer patients for CTD. The results in breast cancer patients were the subject of a poster presentation on December 11, 2024, at the San Antonio Breast Cancer Symposium, and additional significant results in adult breast cancer patients from the OnTarget study have been accepted for presentation as an oral rapid e-poster at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting in June 2025 in Seattle, Washington. 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 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 Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding 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 POC 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 POC results from IITs will be available throughout 2025, Jaguar's expectation that Napo will meet with the FDA in Q2 2025 and discuss the most efficient potential pathway to make crofelemer available to adult breast cancer patients for CTD, and Jaguar's expectation that additional significant results in adult breast cancer patients from the OnTarget study will be presented at the 2025 MASCC Annual Meeting. 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.
