Article discusses results demonstrating parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients with intestinal failure Associated with significant toxicities to patients, PS has a lethal natural history, and PS reduction can potentially extend and save lives SAN FRANCISCO, CA / ACCESS Newswire / January 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that an article published December 29, 2025 in HEALTH, a bi-monthl ...

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) on January 1, 2026 that the company has been awarded a $240,000 grant. Canalevia-CA1 is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. ...

Summary of Jaguar Health Conference Call - December 10, 2025 Company Overview - **Company Name**: Jaguar Health - **Ticker Symbol**: JAGX - **Industry**: Pharmaceuticals - **Focus**: Developing proprietary prescription medicines derived from plants for gastrointestinal distress in humans and animals [1][2] Key Announcements - **Canalivia Approval**: - FDA approved the renewal of conditional approval for Canalivia, a drug for chemotherapy-induced diarrhea in dogs [2][4] - This drug is plant-based, organic, and sustainably harvested [2] - Represents an unmet medical need in veterinary medicine, as there are no other approved treatments for this condition in dogs [3] - **Financial Support**: - Received a $250,000 grant to support the trial design for full approval of Canalivia [4] - Stock price increased by 20%-25% following the announcement [5] - **Expansion Plans**: - Seeking to expand the indication from chemotherapy-induced diarrhea to all types of diarrhea in dogs [5][6] - Filed for advice with the European Medicines Agency (EMA) to potentially gain approval for acute diarrhea in dogs based on existing trial data [5][12] Market Insights - **Veterinary Market Size**: - Approximately 90 million dogs in the U.S., with an estimated 15% experiencing acute diarrhea at some point [9] - About 50% of dogs over the age of 10 are expected to experience cancer, leading to a significant need for supportive care [7][8] - **Mechanism of Action**: - Canalivia works by normalizing ion flow in the gut, which mitigates dehydration and water loss associated with diarrhea [10] - Current treatments often involve unapproved antibiotics, which are facing scrutiny due to resistance issues [10] Regulatory Considerations - **Conditional Approval**: - Conditional approval allows for limited promotion and prescribing, necessitating full approval for broader use [13] - The company aims to secure full approval within five years through confirmatory studies [4] Future Catalysts - **Upcoming Developments**: - 2025 is expected to be a pivotal year with multiple catalysts based on clinical data and regulatory clarity [15] - Focus on partnerships to enhance business development and secure non-dilutive funding [11] Conclusion - Jaguar Health is positioned to address significant unmet needs in the veterinary market with its plant-based therapies, particularly for gastrointestinal issues in dogs. The company is actively pursuing regulatory approvals and market expansion, which could lead to substantial growth opportunities in the coming years [1][15]

Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, ...

Jaguar CEO Lisa Conte presenting December 10 from 3:25pm - 3:35pm Eastern at the Emerging Growth Conference to provide updates on near-term catalysts; Click here to register Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Gro ...

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Core Insights - Crofelemer has the potential to extend the lives of patients with microvillus inclusion disease (MVID), a rare genetic disorder affecting infants and children [1] - The company has submitted an amended protocol to the FDA for a placebo-controlled clinical trial of crofelemer in pediatric MVID patients, aiming for expedited approval [1] - MVID patients face a lethal natural history and require parenteral support, which can be reduced by up to 37% with crofelemer, marking a significant breakthrough [1] Company Developments - Jaguar Health, Inc. and its subsidiary Napo Pharmaceuticals are actively pursuing the development of crofelemer for treating intestinal failure in MVID patients [1] - The ongoing clinical trial is a critical step towards obtaining approval for a treatment that currently has no approved options in any region [1] Industry Context - The lack of approved treatments for MVID highlights a significant unmet medical need in the pediatric population affected by this disorder [1] - The potential reduction of parenteral support by crofelemer could alleviate associated toxicities and comorbidities, improving the quality of life for these patients [1]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Viewpoint - Jaguar Health is conducting an investor webcast to discuss its growth prospects and market strategies, emphasizing the importance of understanding forward-looking statements and their inherent uncertainties [2][3]. Group 1: Company Growth and Market Prospects - Management is optimistic about the company's continued growth prospects, although there are uncertainties regarding market acceptance of its products and the impact of competitive products and pricing [2][3]. - The company is focused on product initiatives, including those in the development stage, which may achieve scientific objectives or meet regulatory requirements [2][3]. Group 2: Financial Reporting and Disclosures - Jaguar Health supplements its GAAP financial statements with non-GAAP EBITDA and non-GAAP recurring EBITDA, indicating a commitment to transparency in financial reporting [4].

Financial Data and Key Metrics Changes - The combined net revenue for Q3 2025 was approximately $3.1 million, representing a 4% increase compared to Q2 2025 revenue of approximately $3 million [4][18] - Loss from operations decreased by $24,000 from $7.2 million in Q3 2024 to $7.3 million in Q3 2025 [19] - Non-GAAP recurring EBITDA for Q3 2025 was a net loss of $8.9 million, compared to a loss of $9.2 million in Q3 2024 [20] - Net loss attributable to common shareholders decreased by $352,000 from $9.9 million in Q3 2024 to $9.5 million in Q3 2025 [20] Business Line Data and Key Metrics Changes - Mytesi prescription volume increased by approximately 0.9% in Q3 2025 over Q2 2025, but decreased by 3.6% compared to Q3 2024 [18] Company Strategy and Development Direction - The company aims to negotiate business development partnerships for licensed rights to develop and commercialize late-stage health products, focusing on generating non-dilutive funding [5][21] - Key late-stage initiatives include orphan indications of Crofelemer for intestinal failure associated with MVID and cancer therapy-related diarrhea [5][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about multiple expected near-term catalysts for Crofelemer, viewing them as significant and potentially transformative for patients and stakeholders [21] - The company anticipates that these catalysts will lead to collaborations, business development, and licensing deals, supporting late-stage products and programs towards regulatory approval [21] Other Important Information - Crofelemer has shown a groundbreaking reduction of parenteral support of up to 37% for intestinal failure patients, which is significant given the lack of approved treatments for MVID [8][9] - The company is in discussions with multiple potential animal health partners to expand the use of Canalivia for general diarrhea in dogs [14] Q&A Session Summary - No specific questions and answers were provided in the content, thus this section is not applicable.