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]

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.

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, and equaled Q3 2024 revenue of approximately $3.1 million [4][19] - 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 [19] 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 crofelemer for orphan indications related to intestinal failure and cancer therapy-related diarrhea, with plans for expedited regulatory pathways [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the convergence of key clinical and regulatory catalysts expected to enhance value for stakeholders, including patients and shareholders [5][21] - The company anticipates significant collaborations and licensing deals that will support late-stage product development and regulatory approval [21] Other Important Information - Crofelemer has shown a groundbreaking reduction of parenteral support by up to 37% for patients with intestinal failure, which is significant given the lack of approved treatments for MVID [9][10] - The company is in discussions with multiple potential partners for the commercialization of Canalivia, an animal health product for chemotherapy-induced diarrhea in dogs [16] Q&A Session Summary - No specific questions or answers were provided in the content regarding the Q&A session.