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Crofelemer can potentially extend lives of MVID patients - infants and children who face the lethal natural history of the disease Parenteral support reduction of up to 37% is groundbreaking; No approved treatments exist for MVID in any region SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible expedited approval pathway for crofelemer for treatment of intestinal ...

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PresentationOperator Greetings, and welcome to the Jaguar Health's Investor Webcast. [Operator Instructions] As a reminder, this conference is being recorded. Before I turn the call over to management, I'd like to remind you that management make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, product initiatives, including products in the ...

Jaguar Health (NasdaqCM:JAGX) Q3 2025 Earnings Call November 17, 2025 08:30 AM ET Company ParticipantsLisa Conte - Founder, President, and CEOCarol Lizak - CFOOperatorGreetings and welcome to the Jaguar Health Investor Webcast. At this time, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Before I turn the call over to management, I'd like to remi ...

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.

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36714 JAGUAR HEALTH, INC. (Exact name of registrant as specified in its charter) (State or other jurisdict ...

Core Insights - Crofelemer has the potential to significantly extend and save the lives of patients with microvillus inclusion disease (MVID) by reducing the volume of total parenteral support (PS) necessary for their survival [1] - The groundbreaking reduction in PS volume of up to 37% is unprecedented, highlighting the drug's potential impact [1] - Currently, there are no approved treatments for MVID, making this development particularly noteworthy [1] Company and Industry Summary - Jaguar Health, Inc. (NASDAQ:JAGX) and its family company Napo Pharmaceuticals presented initial results from an independent investigator-initiated trial (IIT) of crofelemer at the NASPGHAN Annual Meeting [1] - The trial focused on pediatric intestinal failure, specifically targeting patients with MVID and short bowel syndrome (SBS-IF) [1] - MVID is characterized by the intestines not functioning properly, which is a common issue among patients with intestinal failure due to short bowel syndrome [1]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Summary of Jaguar Health Conference Call Company Overview - **Company**: Jaguar Health (Ticker: JAGX) - **Industry**: Pharmaceutical, specifically focusing on plant-based drug development for gastrointestinal conditions and rare diseases [1][2] Core Points and Arguments - **Current Status**: Jaguar Health is in a pivotal phase with multiple catalysts and inflection points in drug development, particularly for Crofelemer, which is FDA-approved for chronic diarrhea in HIV/AIDS patients under the brand name Mytesi [3][4] - **Unique Product**: Crofelemer is the only oral drug approved under botanical guidance, providing exclusivity and a significant barrier to generic competition [3][4] - **Market Focus**: The primary focus remains on the human market, with Crofelemer also conditionally approved for chemotherapy-induced diarrhea in dogs [4][27] - **Clinical Trials**: Ongoing clinical trials include: - Phase 3 for cancer therapy-related diarrhea, with statistically significant results in breast cancer patients [6][8] - Phase 2 studies for rare diseases like short bowel syndrome and microvillous inclusion disease (MVID) [6][21] - **Regulatory Engagement**: Recent FDA meetings have clarified pathways for expedited approval, particularly for metastatic breast cancer patients [7][11] Financial and Market Insights - **Sales Growth**: Mytesi sales are growing at approximately 5% annually, driven by the established market presence [29] - **Market Potential**: The market for short bowel syndrome is estimated at $4.5 billion, indicating significant commercial potential [23] - **Cost Implications**: Managing diarrhea in cancer patients can triple healthcare costs due to hospitalizations and rehydration needs [15] Upcoming Catalysts - **Orphan Drug Designation**: The recent orphan drug designation for Crofelemer in metastatic breast cancer is expected to enhance business development discussions and attract larger deals [30][31] - **Clinical Data Presentation**: Upcoming presentations at medical conferences will showcase the impact of Crofelemer on pediatric patients with MVID and short bowel syndrome [22] Additional Insights - **Patient Advocacy**: The company emphasizes the importance of patient quality of life, with testimonials highlighting the severe impact of diarrhea on cancer patients [9][10] - **Safety Profile**: Crofelemer has a strong safety profile, with no serious drug-related adverse events reported in clinical trials [26] - **Veterinary Insights**: The experience in the veterinary market with Canalevia CA1 is expected to inform human market strategies, as similar gastrointestinal issues are observed in both dogs and humans [32][33] Conclusion Jaguar Health is positioned at a critical juncture with its innovative, plant-based therapies addressing significant unmet medical needs in both human and veterinary markets. The company is actively pursuing regulatory approvals and partnerships to expand its market presence and enhance patient care.