JAGX

This article first appeared on GuruFocus. Release Date: August 19, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Jaguar Health Inc (NASDAQ:JAGX) has successfully completed a transformative US Commercial out-license agreement with FuturePak, securing $18 million in non-dilutive upfront capital and positioning the company for additional milestone payments. The company's lead rare disease program for intestinal failure, particularly in MVID, has shown groundbreaking clinical results, with reductions in parenteral support requirements of up to 48% in MVID patients and 40% in SBS-IS patients, far exceeding the clinically relevant threshold of 10-15%. Jaguar Health Inc (NASDAQ:JAGX) is strategically focused on a rare disease program with a global market opportunity estimated at approximately $8 billion for short bowel syndrome and over $1 billion for MVID, with no approved treatments or competing clinical development for MVID. The company has a strong IP position with approximately 185 issued patents and a de facto exclusivity shield due to its FDA-approved botanical drug status, providing perpetual protection against generics and enhancing terminal value for potential partners. Jaguar Health Inc (NASDAQ:JAGX) is advancing its pivotal MVID clinical trial, which is fully enrolled, and plans to file for breakthrough therapy designation in Q4 2026, potentially leading to FDA approval by the end of 2027, with a clear regulatory pathway for Europe in 2028. The company is expanding its animal health franchise with the upcoming launch of Neonorm Dog, leveraging existing relationships and distribution channels like Amazon and Chewy to generate additional revenue streams. Jaguar Health Inc (NASDAQ:JAGX) reported a significant decrease in prescription product net revenue, down 60% year-over-year in Q2 2026, due to the FuturePak licensing agreement, which directs US revenues to FuturePak. The company's net loss attributable to common shareholders increased by approximately $2.3 million in Q2 2026, reaching $12.7 million, driven by higher interest expenses, fair value adjustments, and debt extinguishment losses. Jaguar Health Inc (NASDAQ:JAGX) faces a high cash burn rate, with non-GAAP recurring EBITDA losses of $8.4 million in Q2 2026, and the company's ability to fund operations depends on securing additional non-dilutive partnerships or financing. The company's reliance on a single-digit number of patients for its MVID NDA filing, while justified by the ultra-rare disease prevalence, may pose regulatory and commercial risks, including potential challenges in demonstrating broad efficacy and safety. Jaguar Health Inc (NASDAQ:JAGX) has a complex financial structure with liability-classified warrants and notes payable designated as fair value options, leading to volatility in reported earnings and potential dilution for shareholders. The company's strategic shift away from direct commercialization of Mytesi has reduced its control over US sales and revenue, creating dependence on FuturePak's performance and limiting direct market feedback. Warning! GuruFocus has detected 3 Warning Signs with JAGX. Is JAGX fairly valued? Test your thesis with our free DCF calculator. Q: What are the key clinical results for the company's lead rare disease program, and what is the timeline for regulatory submission?A: Lisa Conte (CEO) highlighted groundbreaking results presented at the ESPGHAN meeting in June 2026 for the oral liquid formulation of crofelemer in intestinal failure patients. In one MVID patient, weekly parenteral support requirements normalized to body weight were reduced by up to 48%, and in two SBS-IF patients, by up to 40%, following over 12 months of therapy. This far exceeds the 10-15% reduction considered clinically relevant. The company expects to complete the clinical package by the end of 2026, file an NDA for MVID in Q2 2027, and potentially achieve US approval by the end of 2027 if granted Breakthrough Therapy Designation. Q: Can you provide an update on the pivotal MVID clinical trial and the expanded access program?A: Lisa Conte (CEO) stated that the pivotal randomized, double-blind, placebo-controlled trial for MVID is fully enrolled at sites in the US, Italy, and the UAE. The FDA authorized a treatment-only extension phase, and every single patient from the blinded portion qualified to continue. Additionally, an infant with MVID treated under an FDA-authorized expanded access program is now a year old, thriving, and has reduced parenteral support from 22 hours to 18 hours per day. The company estimates it is treating approximately 4% of the MVID patient population. Q: What is the company's business development strategy for the intestinal failure program?A: Lisa Conte (CEO) emphasized that the company is actively seeking a development and commercialization partner for its rare disease program. She cited recent third-party transactions, including Eli Lilly's licensing of a GLP-2 antagonist for short bowel syndrome for up to $1.26 billion and Jazz Pharmaceuticals' agreement to acquire Actio Biosciences for up to $1.32 billion, as validation of the market opportunity. The global market for short bowel syndrome with intestinal failure is estimated to reach approximately $8 billion by 2033, and the MVID market is estimated at over $1 billion. Q: How does the company view its competitive position for crofelemer in intestinal failure?A: Lisa Conte (CEO) noted that there is nothing in development for MVID, making crofelemer the only candidate. For SBS, the approved GLP-2 growth hormone approach is not standard of care, has many side effects, and is only used in about 5-7% of patients. GLP-2s cannot be used on a lifelong chronic basis, whereas crofelemer could, and could even be used in conjunction with GLP-2s. Crofelemer is a locally acting anti-secretory agent that reduces fluid and electrolyte losses, offering a paradigm-shifting opportunity. Q: What is the status of the FuturePak out-licensing deal and its financial impact?A: Lisa Conte (CEO) and Carol Lizak (CFO) detailed that the company received $16 million upfront in January 2026 upon closing the US Commercial out-license agreement with FuturePak for Mytesi and Canalevia-CA1. The company subsequently satisfied post-closing conditions and received an additional non-dilutive $2 million holdback. Jaguar remains the manufacturer of crofelemer at a profit and is eligible for up to another $17 million in milestone payments. This deal allows the company to focus 100% of its human development efforts on the rare disease program. Q: What were the key financial results for the second quarter of 2026?A: Carol Lizak (CFO) reported that prescription product net revenue was approximately $1.2 million in Q2 2026, a 60% decrease compared to $2.9 million in Q2 2025, primarily due to the FuturePak agreement. However, the loss from operations decreased by about $400,000 to $7.6 million, driven by a $2.1 million reduction in operating expenses. Net loss attributable to common shareholders increased to $12.7 million from $10.4 million in the prior year, due to increased interest expense and fair value adjustments on warrants and notes payable. Q: Can you elaborate on the company's intellectual property strategy for crofelemer?A: Lisa Conte (CEO) explained that crofelemer's status as the first and only oral prescription drug approved by the FDA under botanical guidance functions as a de facto and perpetual IP exclusivity shield. There is no practical pathway to bring a generic to market, providing exclusivity "to infinity and beyond." This is a powerful asset when doing terminal value calculations with potential commercial partners, as there is no patent cliff. Q: What is the company's plan for the animal health business?A: Lisa Conte (CEO) announced the anticipated commercial launch of a new product called Neonorm Dog, a non-prescription, plant-based product intended to support normal stool consistency and GI fluid balance in dogs. The product will be available through online and animal health retail channels, including Amazon and Chewy, leveraging relationships built during the promotion of Canalevia-CA1. This is a small business segment, as the company's primary focus is on human rare disease programs. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Company remains sharply focused on its ongoing global development program for crofelemer for rare intestinal failure (IF) diseases; as announced, presentation at ESPGHAN 2026 described additional groundbreaking results of evaluation of crofelemer as adjunctive oral therapy for the treatment of pediatric IF, which demonstrate reduction of parenteral support normalized to body weight of up to 48% in patient with the ultrarare microvillus inclusion disease (MVID); company expects clinical package for NDA for MVID to be ready by end of 2026, allowing submission of NDA in Q2 2027 REMINDER: Jaguar to host investor webcast Wednesday, August 19 at 4:30 p.m. Eastern regarding Q2 2026 financials and company updates (click here to register) SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated second-quarter 2026 financial results. 2026 SECOND QUARTER COMPANY FINANCIAL RESULTS: License and Grant Revenue: Effective January 12, 2026, Jaguar entered a U.S. commercial licensing agreement with Woodward Specialty, LLC ("Woodward"), an affiliate of privately held Future Pak, LLC ("Future Pak"). Under the terms of the agreement, Future Pak is now the exclusive U.S. marketer for the Company's Mytesi® and Canalevia®-CA1 products. License revenues for the initial $16 million upfront payment, in addition to the $3 million payment for early termination of the Buy-Back Option under this agreement, were recognized by the Company in the first quarter of 2026. As announced in August 2026, Jaguar has satisfied the closing conditions required to receive payment of the non-dilutive $2 million holdback amount of the upfront fee from Future Pak. Napo remains the manufacturer of crofelemer and Mytesi and supplies product to Future Pak at cost-plus terms. Additionally, the Company recognized license fees of $43,000 in the second quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of June 30, 2026, the total deferred revenue associated with this contract amounts to $468,000. Federal grant revenue recognized in the second quarter of 2026 for the clinical study related to the treatment of chemotherapy-induced diarrhea ("CID") in dogs was $25,520 and none in 2025. Prescription Product Revenue, Net: The total net revenue for the Company's prescription products (Mytesi, Gelclair, and Canalevia-CA1) was approximately $1.2 million in the second quarter of 2026, which was compromised primally of sales of Mytesi at cost-plus to Future Pak. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1, effective from January 12, 2026, are directed to Future Pak. Future Pak is privately held and does not report Mytesi sales. Compared to the second quarter of 2025, the number of Mytesi bottles the Company sold in the second quarter of 2026 increased significantly and commercial costs were substantially decreased. The decision to enter a commercial license agreement with Future Pak aligns with Jaguar's strategic focus on advancing the development of its powder-for-oral-solution formulation of crofelemer for rare-disease indications related to intestinal failure in humans. The total net revenue for the Company's prescription products in the second quarter of 2026 represents a decrease of approximately 2% compared to the first quarter of 2026, when total net revenue for prescription products was approximately $1.2 million. Additionally, prescription products net revenue decreased by 60% compared to the second quarter of 2025, when total revenues amounted to approximately $2.9 million. Neonorm™: Revenues for the non-prescription Neonorm products were consistent and minimal for the second quarters of 2026 and 2025. Cost of Product Revenue: The total cost of product revenue increased by $0.5 million, from $0.5 million for the quarter ended June 30, 2025 compared to about $1.0 million for the quarter ended June 30, 2026. The increase in cost was due to sales of inventory to Future Pak in the second quarter of 2026 under the licensing and supply agreement. Research and Development: The R&D expense increased by approximately $0.1 million, from $3.2 million for the quarter ended June 30, 2025 compared to $3.3 million for the quarter ended June 30, 2026, primarily due to progress of the development of crofelemer into a powder formulation, a process called lyophilization. This formulation is the new product formulation utilized in the rare disease intestinal failure clinical trials and anticipated for regulatory approval and commercialization. Sales and Marketing: The Sales and Marketing expense decreased by approximately $2.5 million, from $2.5 million for the quarter ended June 30, 2025 to approximately $5,000 for the quarter ended June 30, 2026. The decrease was due to the dissolution of the Jaguar/Napo Sales and Marketing Group as of January 12, 2026 following the licensing of Mytesi and Canalevia-CA1 to Future Pak. General and Administrative: The G&A expense decreased by approximately $0.3 million, from $4.4 million in the quarter ended June 30, 2025 to $4.7 million in the quarter ended June 30, 2026, largely due to an overall decrease in legal and compliance fees, public company expenses, stock-based compensation and travel expenses. Loss from Operations: The loss from operations decreased $0.4 million, going from a loss of $8.0 million in the quarter ended June 30, 2025, to a loss of $7.6 million in the quarter ended June 30, 2026. This change was primarily due to a $1.7 million decrease in product net revenue, which was offset by a reduction in operating expenses of approximately $2.1 million, attributed to the Future Pak licensing agreement. Net Loss: Net loss attributable to common shareholders increased by approximately $2.3 million, from a loss of $10.4 million in the quarter ended June 30, 2025 to a loss of $12.7 million in the quarter ended June 30, 2026. In addition to the loss from operations: Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the second quarters of 2026 and 2025 were a net loss of approximately $8.4 million and $7.9 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. 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") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. 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 https://jaguar.health Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com 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 Mytesi.com. 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 www.fda.gov/safety/medwatch or call 1-855-273-0468. Please see full Prescribing Information at: https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf 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 labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the clinical package for the NDA (New Drug Application) for crofelemer for MVID will be ready by end of 2026, Jaguar's expectation that submission of the NDA for crofelemer for MVID will take place in Q2 2027, Jaguar's expectation that it will hold an investor webcast on August 19, 2026, and Jaguar's expectation that its powder formulation of crofelemer utilized in the rare disease IF clinical trials will receive regulatory approval and may be approved for commercialization. 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. Source: Jaguar Health, Inc. Contact: [email protected] Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

Company remains sharply focused on its ongoing global development program for crofelemer for rare IF diseases Near-term milestones for IF program buttressed by continuing groundbreaking results of study, which demonstrate reduction of parenteral support normalized to body weight of up to 48% in patient with the ultrarare pediatric microvillus inclusion disease (MVID) SAN FRANCISCO, CA / ACCESS Newswire / June 30, 2026 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar") family company Napo Pharmaceuticals (Napo) today provided a recap of presentations of the oral liquid crofelemer as adjunctive therapy in pediatric intestinal failure (IF) patients at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in Lille, France. Napo provided additional data from ongoing investigational studies with oral liquid crofelemer in pediatric patients with IF due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS). Since IF patients cannot orally absorb adequate nutrients, electrolytes and fluids, they require lifelong total parenteral nutrition (TPN) with or without supplemental intravenous fluids, which together comprise parenteral support (PS), for up to seven days per week and up to 20+ hours per day. While PS is supportive, palliative and lifesaving, it is associated with serious complications. As presented at ESPGHAN 2026, the results of ongoing investigations of liquid oral crofelemer demonstrate substantial reductions of PS and PS normalized to body weight in pediatric IF patients dosed orally for more than one year, with no significant clinical or laboratory abnormalities. In one MVID patient, the weekly PS requirements normalized to body weight have been reduced by up to 48% following >12 months of liquid oral high-dose crofelemer therapy. In two pediatric SBS-IF patients, weekly PS requirements normalized to body weight were reduced up to 40% following >12 months of liquid oral high dose crofelemer therapy. "Liquid oral crofelemer as adjunctive therapy to PS has been well tolerated with no significant clinical or laboratory abnormalities throughout the ongoing treatment period of >12 months in these pediatric IF patients with MVID or SBS. In addition, the reductions in weekly PS requirements normalized to body weight with excellent tolerability support the continued development of liquid oral crofelemer as the first oral adjunctive therapy for pediatric intestinal failure patients receiving lifelong PS," said Dr. Pravin Chaturvedi, Chair of Scientific Advisory Board and Chief Scientific Officer of Napo and Jaguar. "We remain sharply focused on and committed to our global development program for our novel liquid oral crofelemer formulation as adjunctive treatment for the management of rare IF conditions such as MVID and SBS," said Lisa Conte, Jaguar's founder, president, and CEO. "Our IF program is expected to continue to provide clinical milestones and is the subject of business development discussions with the potential to bring in non-dilutive funds from potential licensee partners. If appropriate, Jaguar plans to apply for Breakthrough Therapy Designation for crofelemer for the indication of MVID, with a planned filing of an NDA (New Drug Application) with the U.S. Food and Drug Administration (FDA) for this indication in mid-2027." One e-poster was presented on June 27, 2026 at ESPGHAN titled Exploratory Single-Arm, Open-Label Non-Randomized Trial Evaluating the Safety and Effectiveness of Crofelemer in Pediatric Patients with Intestinal Failure, and the associated abstract can be viewed by clicking here. Another report of the evaluation of novel liquid oral crofelemer adjunctive therapy, for the treatment of IF in an infant through an ongoing expanded access program in the U.S., was presented for e-poster viewing at ESPGHAN 2026. The study demonstrated that total daily parenteral nutrition volume and caloric delivery remained stable throughout crofelemer therapy despite ongoing growth, while stool output was simultaneously reduced. The abstract, titled Crofelemer for Symptom Management in Microvillus Inclusion Disease: A Case Report in an Infant, can be viewed by clicking here. The European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) is a multi-professional organization whose aim is to promote the health of children with special attention to the gastrointestinal tract, liver and nutritional status, through knowledge creation, the dissemination of science based information, the promotion of best practice in the delivery of care and the provision of high quality education for pediatric gastroenterology, hepatology and nutrition professionals in Europe and beyond. 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. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. For more information about: Jaguar Health, visit https://jaguar.health Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that its intestinal failure program will continue to provide clinical milestones, Jaguar's expectation that the opportunity may exist to bring in non-dilutive funds from potential licensee partners to support the intestinal failure program, Jaguar's plans to pursue Breakthrough Therapy designation for crofelemer for the indication of MVID, and Jaguar's expectation that the company will file an NDA with the FDA for the MVID indication in mid-2027. 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] SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

Whole leaf coca extract under evaluation is Magdalena's drug candidate for post GLP-1 weight loss management Toronto, Ontario--(Newsfile Corp. - June 18, 2026) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light Holland", "Red Light", or the "Company") is an Ontario based organization advancing innovation and research within the legal psychedelic sector. Following its acquisition of Filament Health Corp. ("Filament"), the Company has expanded its pharmaceutical grade manufacturing, regulatory, and clinical research capabilities, supporting the advancement of naturally derived drug development. Through the Filament acquisition, the Company also holds Filament's interest in Magdalena Biosciences, Inc. ("Magdalena"), a US based joint venture formed by Filament and Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar"). The Company is pleased to report that Magdalena has announced positive results of a preclinical study demonstrating that a novel extract derived from the leaves of the coca plant prevented weight gain in mice placed on a high fat diet, without reducing food intake or increasing physical activity. The coca leaf extract under evaluation is Magdalena's prescription drug candidate for post-GLP-1 weight loss management, intended for development under the U.S. Food and Drug Administration's Botanical Guidance. It is common for people to regain weight after stopping GLP-1 medications, as these drugs help reduce appetite and increase feelings of fullness while they are being taken. When treatment is discontinued, those effects diminish, and the body's mechanisms that regulate hunger and body weight may promote weight gain. Magdalena's thesis is that the coca leaf extract under evaluation may have the potential to serve as a weight maintenance therapy following cessation of GLP-1 therapy, addressing a significant unmet need for safe, long term weight management solutions. The 20 day preclinical study was conducted in Alberta, Canada, in collaboration with the Borgland Lab at the University of Calgary, where Stephanie Borgland, PhD, served as Principal Investigator. The coca leaf used in the research and development program was provided to Magdalena by Empresa Nacional de La Coca (ENACO), a Peruvian state company dedicated to the commercialization of the coca leaf and its derivatives, under an Internationally Recognized Certificate of Compliance (IRCC) consistent with the Nagoya Protocol requirements of Peru. Indigenous peoples and healers in the Andean region have utilized coca for centuries to manage hunger and fatigue. "This is an encouraging early result from Magdalena Biosciences and a clear example of the broader value created through our acquisition of Filament," said Todd Shapiro, Chief Executive Officer and Director of both Red Light and Filament. "Beyond Filament's leadership in standardized, naturally derived psilocybin, the acquisition gives Red Light an interest in a botanical drug development program addressing a large and growing unmet need in weight management. We look forward to supporting Magdalena and our partners at Jaguar as this candidate advances under the FDA's Botanical Guidance." Filament is Red Light's wholly owned subsidiary and a partner, alongside Jaguar, in the Magdalena Biosciences joint venture. The Company believes that the development of standardized, naturally derived botanical medicines, advanced under quality controlled and regulatory conscious frameworks, can offer new mechanisms of action while being potentially safer than chemically synthesized small molecule drugs. About Red Light Holland Red Light is an Ontario based organization advancing a focused strategy within the legal psychedelic sector, centered on consensual data collection and R&D initiatives designed to expand naturally occurring drug development, understanding of psilocybin use and consumer experiences. In parallel, the Company operates commercial activities across Europe and North America, including psilocybin truffle sales in the Netherlands' legal market and mushroom home grow kits offered through B2B and DTC channels, in compliance with applicable laws. About Filament Health Filament Health is a clinical stage natural psychedelic drug development company. Filament believes that safe, standardized, naturally derived psychedelic medicines can improve the lives of many, and its mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. Filament is paving the way with the first ever natural psychedelic drug candidates. About Magdalena Biosciences Magdalena Biosciences, Inc. is a US based joint venture formed by Jaguar Health, Inc. and Filament Health Corp. in 2023 to develop novel, natural prescription medicines derived from plants for weight gain prevention and mental health indications. Magdalena emerged from Jaguar's Entheogen Therapeutics Initiative (ETI). Boulder, Colorado based One Small Planet, founded by Will Peterffy, has committed funding of US$1,000,000 to the venture. About Jaguar Health Jaguar Health, Inc. (NASDAQ: JAGX) develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal disease states. Jaguar is Filament's partner in the Magdalena Biosciences joint venture. For additional information on Red Light: Todd ShapiroChief Executive Officer & DirectorTel: 647-204-7129Email: [email protected]: www.RedLight.co Cautionary Statement Regarding Forward-Looking Statements This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Examples of such information include statements with respect to: the results of the preclinical study announced by Magdalena and the interpretation of those results; the potential for the coca leaf extract under evaluation to serve as a weight maintenance therapy following cessation of GLP-1 therapy; the future development, commercialization, and regulatory approval of the coca leaf extract drug candidate, including under the FDA's Botanical Guidance; the Magdalena Biosciences joint venture and the Company's interest therein through Filament; the recently completed acquisition of Filament Health and the expected integration of Filament's infrastructure and intellectual property; and the expected demand for standardized, naturally derived botanical medicines. Forward-looking information in this news release is based on certain assumptions and expected future events, namely: that preclinical results may inform, but are not necessarily predictive of, the outcomes of any future clinical studies; the continued advancement of the coca leaf extract drug candidate by Magdalena and its partners; the performance by the joint venture partners of their respective obligations; the continued supply of coca leaf and the ability to obtain and maintain any required regulatory permits and approvals, including import and export authorizations; the successful integration of Filament Health following the completed acquisition; and general business, market and economic conditions. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, namely: the risk that preclinical results do not translate into comparable clinical outcomes; the risk that the drug candidate does not advance or obtain regulatory approval; regulatory or enforcement developments affecting the legal framework for coca and botanical drug research and supply; the risk that integration of Filament Health is not completed as anticipated; delays in regulatory permitting, including import and export authorizations; and adverse changes in the regulatory or political landscape affecting botanical drug research and access. Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. Source: Red Light Holland Corp. To view the source version of this press release, please visit https://www.newsfilecorp.com/release/302047

Whole leaf coca extract under evaluation is Magdalena's drug candidate for post-GLP-1 weight loss management SAN FRANCISCO, CA / ACCESS Newswire / June 18, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the results of a preclinical study initiated by Magdalena Biosciences ("Magdalena"), a US-based joint venture formed by Jaguar and Canada-based Filament Health Corp. ("Filament"), demonstrate that a novel extract derived from leaves of the coca plant prevented weight gain in mice submitted to a high fat diet without reducing food intake or increasing physical activity. The coca leaf extract under evaluation is Magdalena's prescription drug candidate for post-GLP-1 weight loss management, intended for development under the U.S. Food and Drug Administration's Botanical Guidance. It is common for people to regain weight after stopping GLP-1 medications because these drugs help reduce appetite and increase feelings of fullness while they are being taken. When treatment is discontinued, these effects diminish, and the body's mechanisms that regulate hunger and body weight may promote weight gain. "We're very pleased with the results of this 20-day preclinical study, which was conducted at the University of Calgary in Alberta, Canada," said Steven King, PhD, Jaguar's Chief Sustainable Supply and Ethnobotanical Research Officer and a founding Advisor to Magdalena. "The study results support our thesis that the coca leaf extract under evaluation may have the potential to serve as a weight maintenance therapy following cessation of GLP-1 therapy. The rebound effect observed after discontinuation of GLP-1 therapies, characterized by weight gain, highlights a significant unmet need for safe, long-term weight management solutions. A coca extract-based prescription drug developed under the FDA's Botanical Guidance, which is likely to have a low abuse potential, would logically fit into this therapeutic niche." Indigenous peoples and healers in the Andean region of Peru have utilized coca for centuries to manage hunger and fatigue. The coca leaf that is part of this Magdalena research and development program was provided to Magdalena by Empresa Nacional de La Coca (ENACO), a Peruvian state company dedicated to the commercialization of the coca leaf and derivatives, with an Internationally Recognized Certificate of Compliance (IRCC) in compliance with the Nagoya Protocol requirements of Peru. "We believe the development of FDA-approved drugs from ‘whole extract' coca leaf can provide therapeutic benefit, and that the development process will benefit the people of Peru, who have been sustainably producing coca leaves for several thousand years. Plant-derived medicines offer potential new mechanisms of action while being potentially safer than chemically synthesized small molecule drugs that may have ‘off target' effects," Dr. King said. "We are grateful to the people of the Andean region who have domesticated the sacred plant, ‘mama coca,' which is and has been part of the medical systems of indigenous communities for an estimated 8,000 years." "We are pleased that the Borgland Lab at the University of Calgary was able to collaborate with Magdalena Biosciences to evaluate the biological activity of coca in our facility," said Stephanie Borgland, PhD, the Principal Investigator for the preclinical study in mice. ABOUT MAGDALENA BIOSCIENCES Jaguar Health, Inc. and Filament Health Corp. formed Magdalena Biosciences, Inc. as a joint venture in 2023 to develop novel, natural prescription medicines derived from plants for mental health and CNS indications. Boulder, Colorado-based One Small Planet, founded by Will Peterffy, has committed to funding of US$1,000,000. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for weight gain prevention and mental health disorders. ABOUT FILAMENT HEALTH Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates. Learn more at www.filament.health and on Twitter, Instagram and LinkedIn. About the Jaguar Health Family of Companies Jaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. 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 weight gain prevention and mental health indications. For more information about: Jaguar Health, visit https://jaguar.health Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that a ‘whole extract' of coca leaf may have the potential to serve as a weight maintenance therapy following cessation of GLP-1 therapy, the expectation that development of drugs from ‘whole extract' coca leaf can provide therapeutic benefit and that the development process will benefit the people of Peru. 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 a number of 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 Info: [email protected] SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

This article first appeared on GuruFocus. Release Date: May 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Jaguar Health Inc (NASDAQ:JAGX) reported a significant increase in net revenue, up 816% in Q1 2026 compared to Q1 2025, driven by a transformative out-license agreement. The company executed a strategic out-license agreement with Future Pak for Mytesi and Canalevia-CA1, bringing in meaningful nondilutive funding. Jaguar Health Inc (NASDAQ:JAGX) is focusing on a pivotal stage program for a novel proprietary powder for oral solution formulation of crofelemer, targeting rare intestinal failure indications. The company's intestinal failure program represents a blockbuster global market opportunity, with the short bowel syndrome market estimated to reach $8 billion by 2033. Initial results from a proof-of-concept study showed crofelemer reduced parenteral support needs by up to 37% in pediatric patients with intestinal failure, demonstrating significant clinical benefits. Net revenue for the company's Prescription Products decreased by 62% compared to the fourth quarter of 2025. The company reported a net loss attributable to common shareholders of $7.1 million in Q1 2026, despite improvements from the previous year. Interest expense increased significantly to approximately $700,000 in Q1 2026 due to new notes, impacting overall financial performance. Loss on extinguishment of debt was $600,000 during Q1 2026, indicating financial restructuring challenges. The fair value of financial and hybrid instruments decreased, resulting in a loss of $300,000 in Q1 2026, reflecting volatility in financial instruments. Warning! GuruFocus has detected 6 Warning Signs with JAGX. Is JAGX fairly valued? Test your thesis with our free DCF calculator. Q: Can you elaborate on the strategic decision to out-license Mytesi and Canalevia-CA1 to Future Pak? A: Lisa Conte, CEO, explained that the decision was made to leverage Future Pak's extensive commercial capabilities, which are significantly larger than Jaguar's. This move aligns with Jaguar's strategy to secure nondilutive funding to focus on developing their novel proprietary powder for oral solution formulation of crofelemer for rare intestinal failure indications. Q: What are the financial highlights for the first quarter of 2026? A: Carol Lizak, CFO, reported a significant increase in net revenue, reaching approximately $20.2 million, an 816% increase compared to the first quarter of 2025. This growth was largely driven by the out-license agreement with Future Pak. Income from operations also increased to $10.2 million, compared to a loss of $9.4 million in the same period last year. Q: Could you provide more details on the clinical progress of crofelemer for intestinal failure indications? A: Lisa Conte highlighted that the ongoing clinical trials for crofelemer in pediatric patients with intestinal failure due to MVID have shown promising results, with reductions in parenteral support needs ranging from 12% to 37%. The company is targeting an NDA submission in mid-2027 and is also pursuing breakthrough therapy designation from the FDA. Q: What is the market potential for the intestinal failure program? A: Lisa Conte stated that the global market for short bowel syndrome, including intestinal failure, is estimated to reach approximately $8 billion by 2033. The MVID market alone is valued at over $1 billion. The program represents a significant opportunity to address unmet medical needs and generate substantial financial returns. Q: How does Jaguar plan to fund the development and commercialization of crofelemer for intestinal failure outside the U.S.? A: Lisa Conte mentioned that Jaguar is actively seeking a partner to assist with funding for the final development and commercialization of crofelemer for MVID and SBS-IF outside the United States. The company has demonstrated its ability to secure nondilutive funding through previous deals, such as the one with Future Pak. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. Nov. 17, 2025, 9 a.m. ET Founder, President, and Chief Executive Officer — Lisa Conte Chief Financial Officer — Carol Lizak Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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 development stage, which may achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes its assumptions, expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and Risk Factors sections of the company's Form 10-K for year 2024, which was filed March 31, 2025, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's webcast. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss or not substitute for or superior to, measures of financial performance in conformity with GAAP. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President and Chief Officer (sic) [Chief Executive Officer]. Lisa, the floor is yours. Lisa Conte: Thank you very much. Appreciate that introduction. Hello to everybody. Good morning. My name is Lisa Conte and I'm, Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals, and I'm also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the word Jaguar and Napo interchangeably as I refer to our company. And after I speak this morning, our CFO, Carol Lizak, will provide a recap of the financial highlights for the third quarter of 2025. And I'm going to kick off by once again stealing Carol's thunder as we are pleased to report that our combined net third quarter 2025 revenue of approximately $3.1 million for prescription and nonprescription products including license revenue, increased approximately 4% versus the net Q2 2025 of approximately $3 million. I'm also happy to report that 2025 continues to be the year of convergence of key clinical and regulatory catalysts for Jaguar. Catalysts that we feel will be transformative in terms of the value that they bring to all stakeholders in the company from patients -- very importantly from patients, to shareholders also very important. Simply put, with the recent achievement of these catalysts, our strategy continues to be to negotiate business development partnerships for licensed rights to the development and commercialization of our Human and Animal late-stage health products with the goal of generating non-dilutive funding for Jaguar. We have three key late-stage initiatives that are the subject of business development negotiations. The first is our orphan indications of crofelemer for intestinal failure associated with the congenital diarrheal disease referred to as MVID, microvillus inclusion disease. I'm going to refer to it as MVID and short bowel syndrome, which I'm going to refer to as SBS. And this program refers to crofelemer, though, not our commercialized Mytesi formulation of crofelemer. Crofelemer in a distinct novel, highly concentrated liquid formulation, which is appropriate for the patient condition -- into a liquid formulation from a lyophilized cake. So what is intestinal failure? It's a debilitating lifelong condition that requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of something referred to as TPN, total parenteral nutrition, with supplemental intravenous fluids, which together constitute parenteral support. As you can imagine, already, this sounds terrible. These are patients who can't absorb their nutrients of life, their protein, carbs, et cetera. So they are living on IV nutrition. Most intestinal failure patients require parenteral support up to 7 days a week and sometimes for 20 hours or more a day, hooked up to IV nutrition. Clearly, this is a catastrophic healthcare situation, quality of life situation. Short bowel syndrome is a rare disease of approximately 400 -- 40,000 patients globally. And for this indication, Jaguar has received orphan drug designation in the United States and in Europe. MVID, intestinal failure MVID patients, this is an ultra-rare disease of approximately 100 to 200 patients globally, and we have also received orphan drug designation in the U.S. and Europe. Infants that are born with this genetic defect have a lethal natural history. They do not become adults. They only survive if immediately receiving TPN, total parenteral nutrition, as I mentioned, parental support which has many toxicities associated with it including liver and kidney toxicity, neurodevelopment delay, many more which often become life-threatening. Crofelemer has been shown to have a groundbreaking reduction of parenteral support of up to 37%. And this is important, as you can imagine, for getting -- reducing the amount of time on toxic TPN and parenteral support. This result was presented last week at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition referred to as NASPGHAN. And it's an annual meeting in Chicago, and it was -- the results were presented by the study's primary investigator in the investigator-initiated trial, Dr. Mohamad Miqdady. This is important because the reduction of parenteral nutrition and parenteral support is both potentially life-extending, life-saving and disease progression modifying and provides an opportunity for improved quality of life in this otherwise catastrophic medical and disease situation for the patient and quite frankly, the entire family of the child and his or her caregiving team. This unprecedented result is especially compelling given that no approved treatments exist for MVID, and we're not aware of any approach even in development for MVID. Additionally, as presented at NASPGHAN were two short bowel syndrome patients surviving on parenteral support, parenteral nutrition and parenteral support, which similarly had reductions of approximately 12% in their parenteral support. This result is equally important for the same reason for the opportunity to reduce the toxicity associated with the parenteral support. And also, while some short bowel syndrome patients do have an opportunity to be treated with a growth hormone approach to potentially grow their short bowel. And as an aside, by the way, growth hormone is not a standard of care as many side effects itself. And additionally, it's not even possible in an MVID patient as MVID patients have fully intact guts. They're simply not functioning, so there's nothing to grow. But anyway, that short bowel syndrome, approximately 1/3 of the short bowel syndrome population are patients with surgical reasons for their short bowel and have adaptation issues during which they cannot receive a growth hormone and/or may have a hyper-proliferative circumstance such as cancer and therefore, are definitely not candidates for growth hormone approach. Once again, crofelemer is demonstrating proof of concept in an orphan population with no treatment alternatives, nothing in development. And once again, this is a distinct product from Mytesi, the same active ingredient in crofelemer and will be commercialized globally under a business model associated and appropriate for the incentives for rare diseases. I'll now discuss our other core crofelemer development program, cancer therapy related diarrhea, CTD, a planned label extension of supplemental NDA for the already FDA-approved Mytesi product. This program -- and again, it's a distinct product from the IF highly concentrated liquid formulation is also the subject of ongoing business development negotiations. The key clarifying and coordinating event, once again a separate Type C meeting with the FDA in May of 2025 discussing an expedited pathway for approval in metastatic breast cancer patients based on supportive data of prophylaxis of cancer therapy-related diarrhea in breast cancer patients from the completed Phase III on-target trial, which was presented at San Antonio Breast Cancer Symposium in December of 2024. We're going to combine this with anticipated data from a pivotal randomized withdrawal treatment trial in metastatic breast cancer patients to be initiated in early 2026. In our experience, a randomized withdrawal trial is the optimal design for product that works. And it's a clinical trial design where participants first receive an active treatment and then when, if, they respond, randomly assigned to either continue the active treatment or receive placebo. As a reminder, this trial is with the same formulation and dose as the approved Mytesi for HIV-related diarrhea for which, of course, chronic safety and manufacturing regulatory hurdles have already been approved. Chronic safety or any safety and manufacturing are the two most common reasons why NDAs fail. Again, those have already been achieved with Mytesi. An efficacy end point potentially expands the indication of Mytesi to cancer therapy-related diarrhea under a supplemental NDA and cancer therapy-related diarrhea is a blockbuster opportunity for the patients, of course, and the market opportunity. There are approximately 160,000 metastatic breast cancer patients in the United States, many of whom are on diarrhea causing targeted therapies for the rest of their lives, which thankfully are becoming 5, 10, 15 years of survival sometimes. We have filed for orphan drug designation for metastatic breast cancer indication. Approximately 40% of patients go off their life-saving targeted therapies, specifically because of diarrhea. And now crofelemer has the opportunity to benefit not only patient quality of life, dignity and comfort as important as those supportive care impacts are, though, also impact the outcome of their -- the successful outcome of their cancer therapy. Moving along now to Animal Health side of our business. Our primary activity for Canalevia, our prescription drug candidate of crofelemer, Canalevia is an animal formulation indication that is FDA conditionally approved under the name Canalevia CA-1 for the treatment of chemotherapy-induced diarrhea in dogs. And our primary activity is negotiating with potential partners with which to collaborate to achieve three parallel goals for the drug, expand the U.S. indication for chemotherapy-induced diarrhea in dogs, to the treatment of general diarrhea in dogs, obtain approval in the European Union for Canalevia for general diarrhea in dogs and based on an existing Jaguar study that already exists. And maintain continuity of availability in the United States of Canalevia for the treatment of chemotherapy-induced diarrhea in dogs for which it is already approved again. Remarkably, a cancer patient in the United States experiencing diarrhea can have crofelemer promoted and prescribed if that patient is a dog, a human, not yet. I'm pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally. This is our third ongoing business development negotiation with the goal of bringing nondilutive dollars to recognize the contribution to late-stage drug development and risk reduction Jaguar has achieved with crofelemer for various indications. Timeline associated with these activities for intestinal failure based on a Type C meeting, a distinct meeting from the cancer meeting that we had with the FDA on October 2. We laid out a pathway for potential expedited review based on continued results like we're seeing in the MVID patient for having data that's fileable by potentially the end of 2026, literally based on a single-digit number of patients because of the ultra-rare nature of the disease and the lethal natural history of the disease, also looking next year for breakthrough designation in the United States and PRIME in Europe, programs that help get products approved in an expedited way for ultra-rare disease situation. For cancer therapy-related diarrhea, we would look to complete the trial for the randomized withdrawal by the end of 2026 as well in support of a supplemental NDA filing. So that would be two potential NDA filings from data at the end of 2026 on the Human side. On the Animal Health side, we're looking to close an animal health partnership in the very near future. I'll now hand the discussion over to Carol, our CFO, for a recap of the financial highlights for the third quarter of 2026. Take it away, Carol. Carol Lizak: Good morning, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the third quarter of 2025. The combined net third quarter 2025 revenue of approximately $3.1 million for prescription and nonprescription products, including license revenue, increased approximately 4% versus net second quarter 2025 revenue of approximately $3 million and equaled net third quarter of 2024 revenue of approximately $3.1 million. Mytesi prescription volume increased by approximately 0.9% in the third quarter of 2025 over the second quarter of this year and Mytesi prescription volume in the third quarter of 2025 decreased by 3.6% compared to the volume in the third quarter last year. 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. Loss from operations decreased by $24,000 from $7.2 million in the third quarter of September 30, 2024, to $7.3 million during the same period this year. Non-GAAP recurring EBITDA for the third quarters of 2025 and 2024 were a net loss of $8.9 million and $9.2 million respectively. Net loss attributable to common shareholders decreased by $352,000 from $9.9 million in the quarter ended September 30, 2024, to $9.5 million in the same period in 2025. And that concludes my recap of high-level financials for the third quarter of 2025. I will now hand the discussion back to Lisa. Lisa Conte: Thanks, Carol. Okay. To all members of the Jaguar, Napo, Napo Therapeutics family, we remain fully energized and excited about the multiple expected near-term catalysts for crofelemer in the company, all of which we view as significant value-enhancing and potentially transformative for patients and as I mentioned, all stakeholders, including our shareholders. Pharmaceutical development is a long-term outcome. And these catalysts represent the convergence of key potential inflection points in our major programs that we've worked on for years. And we expect these catalysts to lead to significant collaborations, business development and licensing deals, and the opportunity to bring in nondilutive dollars to support bringing these late-stage products and programs to regulatory approval and reimbursed patient access. This concludes our webcast for today. Thank you all for joining. Have a wonderful Thanksgiving and holiday with your families. And we'll get together again next quarter. Thank you. Before you buy stock in Jaguar Health, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Jaguar Health wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,063!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,369,991!* Now, it’s worth noting Stock Advisor’s total average return is 994% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 21, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Jaguar Health (JAGX) Q3 2025 Earnings Transcript was originally published by The Motley Fool

Net revenue increased 816% in Q1 2026 vs. Q1 2025, and increased 527% in Q1 2026 vs. Q4 2025, buoyed by license of U.S. commercial rights for Mytesi® and Canalevia®-CA1 Company continues its focus on crofelemer development efforts for rare-disease intestinal failure indications; two crofelemer presentations in pediatric intestinal failure patients with microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) to be made at 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in June 2026 REMINDERS: Jaguar to host investor webcast Tuesday, May 26 at 8:30 a.m. Eastern regarding Q1 2026 financials and company updates (click here to register); Jaguar CEO Lisa Conte to present virtually on Thursday, May 28 at 10 a.m. Eastern at Lytham Partners Spring 2026 Investor Conference (click here to register) SAN FRANCISCO, CA / ACCESS Newswire / May 20, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated first-quarter 2026 financial results. 2026 FIRST QUARTER COMPANY FINANCIAL RESULTS: License and Grant Revenue: Effective January 12, 2026, Jaguar entered a U.S. licensing agreement with Woodward Specialty, LLC ("Woodward"), an affiliate of privately held Future Pak, LLC ("Future Pak"). Under the terms of the agreement, Future Pak is now the exclusive U.S. marketer for the Company's Mytesi and Canalevia-CA1 products. License revenues for the $16 million initial payment, in addition to the $3.0 million payment for early termination of the Buy-Back Option under this agreement, were recognized by the Company in the first quarter of 2026. Per the terms of the agreement, an additional $2 million is due to Jaguar upon completion of post-closing conditions. Additionally, the Company recognized license fees of $42,500 in the first quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of March 31, 2026, the total deferred revenue associated with this contract amounts to $510,000. Federal grant revenue recognized in the first quarter of 2026 for the clinical study related to the treatment of chemotherapy-induced diarrhea ("CID") in dogs was $25,000 and none in 2025. Prescription Product Revenue, Net: The total net revenue for the Company's prescription products (Mytesi, Gelclair, and Canalevia-CA1) was approximately $1.2 million, of which approximately $174,000 stemmed from sales of Mytesi inventory in the first 11 days of the first quarter of 2026, with the remaining bulk of the $1.2 million net revenue stemming from sales of Mytesi inventory to Future Pak later in the first quarter of 2026. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1, effective from January 12, 2026, are directed to Future Pak. This decision aligns with Jaguar's strategic focus on advancing the development of its powder-for-oral-solution formulation of crofelemer for rare-disease indications related to intestinal failure in humans. This represents a decrease of 62% compared to the fourth quarter of 2025, when total net revenue for prescription products was approximately $3.2 million. Additionally, prescription products net revenue decreased by 45% compared to the first quarter of 2025, when total revenues amounted to approximately $2.2 million. Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the first quarters of 2026 and 2025. Cost of Product Revenue: The total cost of product revenue increased by $0.64 million, from $0.5 million for the quarter ended March 31, 2025 compared to about $1.2 million for the quarter ended March 31, 2026. The increase in cost was due to sales of inventory to Future Pak in the first quarter of 2026 under the licensing and supply agreement. Research and Development: The R&D expense increased by $0.2 million, from $3.7 million for the quarter ended March 31, 2025 compared to $3.9 million for the quarter ended March 31, 2026, primarily due to progress of the development of crofelemer into a powder formulation, a process called lyophilization. Sales and Marketing: The Sales and Marketing expense decreased by approximately $1.6 million, from $2.5 million for the quarter ended March 31, 2025 to approximately $0.9 million for the quarter ended March 31, 2026. The decrease was due to the dissolution of the Jaguar/Napo Sales and Marketing Group as of January 12, 2026 following the licensing of Mytesi and Canalevia-CA1 to Future Pak. General and Administrative: The G&A expense decreased by approximately $0.8 million, from $4.9 million in the quarter ended December 31, 2025 to $4.1 million in the quarter ended March 31, 2026, largely due to an overall decrease in legal and compliance fees, public company expenses, stock-based compensation and travel expenses. Income from Operations: Income from operations increased $19.6 million, from a loss of $9.4 million in the quarter ended March 31, 2025 to income of $10.2 million in the quarter ended March 31, 2026 largely from the license revenue recognized under the Future Pak agreement and decreased operating expenses. Net Loss: Net loss attributable to common shareholders decreased by approximately $3.4 million, from a loss of $10.5 million in the quarter ended March 31, 2025 to a loss of $7.1 million in the quarter ended March 31, 2026. In addition to the loss from operations: Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the first quarters of 2026 and 2025 were a net loss of $6.4 million and $9.7 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. 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") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. 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 https://jaguar.health Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com 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 Mytesi.com. 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 www.fda.gov/safety/medwatch or call 1-855-273-0468. Please see full Prescribing Information at: https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf 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 labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will hold an investor webcast on May 26, 2026, and Jaguar's expectation that Jaguar management will present at the Lytham Partners Spring 2026 Investor Conference. 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] SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

Image source: The Motley Fool. Friday, April 10, 2026 at 7 a.m. ET Founder, President, and Chief Executive Officer — Lisa Conte Chief Financial Officer — Carol Lizak 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 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. Today's conference is being recorded. And at this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours. Lisa Conte: Thanks very much, Melissa, and thank you, everybody. Hello. Thank you for joining the Investor Webcast today. As you heard, my name is Lisa Conte. I'm the Founder, President, and CEO of Jaguar Health and our wholly-owned subsidiary, Napo Pharmaceuticals, and I am the Chairman of our Italian subsidiary, Napo Therapeutics. So as usual, I may use the words Jaguar and Napo interchangeably to refer to the Company. And after I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the fourth quarter of 2025 last year. And, I am once again pleased to steal Carol's thunder, and I am further pleased to report that our combined net fourth-quarter 2025 revenue of approximately $3.2 million for both our prescription and nonprescription products, including license revenue, increased approximately 5% versus the net Q3 2025 of approximately $3.1 million. Our strategy for 2026 is business development, and I'm pleased to add the description continued business development. And our theme is What's Different Now. Let me start by addressing our achievement of bringing about a transformative business platform at Jaguar. The key event was the closing of a U.S. out-license agreement with Future Pak for Mytesi, our FDA-approved tablet formulation of crofelemer, Mytesi, an agreement that is fully aligned with our strategy to sharply focus our crofelemer development efforts on rare-disease intestinal failure indications. The out-license agreement also covers Canalevia-CA1, crofelemer for the treatment of chemotherapy-induced diarrhea in dogs, as conditionally approved. The key transformative points of this deal are straightforward. First, there's non-dilutive dollars that provide the fuel for the development of our rare-disease pipeline. The deal had $18 million upfront, of which $16 million we have already received. We received when we signed the deal in January, $2 million coming based on certain conditions, and an additional $20 million in milestone payments and other future payments. These are non-dilutive dollars, and we've already received close to $4 million of additional payments above and beyond the $16 million. This is, again, non-dilutive dollars. This has been our vision; this has been our mission. This has been our objective for several years now. Jaguar continues to be the manufacturer of crofelemer, and we are selling it to Future Pak at a profit. So, it now has become a profit center. We have really breakthrough data in the rare-disease area, which I'm going to be talking about in a moment, and near-term development catalysts, clinical catalysts, regulatory catalysts for disease with a natural -- with a lethal natural history, and with endpoints that we're looking at to potentially extend life for this situation. We're in late-stage clinical development in our rare-disease intestinal failure program, and that includes something called MVID, microvillus inclusion disease, which is an ultra-rare congenital diarrheal disorder, and short bowel syndrome with intestinal failure. MVID, we are targeting a New Drug Application for 2027, and that would be coincident with completing a Phase II trial, placebo-controlled trial for short bowel syndrome. For short bowel syndrome, third parties put the market opportunity at about $8 billion by 2023. That's about 100x the size of the Mytesi HIV estimated market size. In that deal, we got an $18 million upfront payment. So that's the enormity and of the blockbuster opportunity in terms of impact on patients, impact on the mortality, the morbidity, the cost to the health care system. And as we are looking to bring in additional partnerships, the type of non-dilutive dollars that we are targeting to bring into this Company. We have really meaningful catalysts in the next 6 to 12 months, as you'll hear as I continue to go through this presentation and a goal to license -- bring in a license deal for rare-disease. That is the key objective of the Company and, as I mentioned, that is our strategy for 2026. We do have a slide that summarizes these points, Carol, I'm not sure if you are able to put that slide up. Terrific. Terrific. As I mentioned, the intestinal-failure program is a blockbuster market, and it's catastrophic for the patients. What is intestinal failure? The intestinal failure is a situation where the patient can't absorb their nutrients of life. Their proteins, their carbs, vitamins, et cetera. So they end up on parenteral nutrition, parenteral support, that's IV support up to 20 hours a day, 7 days a week. So, obviously, hugely catastrophic for quality-of-life, but also for other health issues. It's TPN, parenteral support, but Total Parenteral Nutrition is considered oftentimes as toxic as chemotherapy for a patient, yet necessary for them to live. Otherwise, as I mentioned, it's a lethal natural history for these patients. For an MVID patient, if they are not diagnosed immediately when they're born, they die. And if they are diagnosed, they do go on Total Parenteral Nutrition from the moment that they're born, and they typically don't last beyond their teenage years, first of all, because of the IV interventions, there's infections, there's other problems. But TPN is remarkably toxic to kidneys, to liver, to cognitive function, patients often are on a much slower growth-curve. So, what is the endpoint that we're looking for in our clinical trials? What's the endpoint that we're looking for with crofelemer intervention? It's reduction of TPN and parenteral support by even 5% will be meaningful. And, I was talking with a patient advocate just a couple of weeks ago. And why is that? Because if you can reduce even 5%, 10%, 15% the amount of time that the patient is on parenteral support, it can, for example, allow a child to go off their IV nutrition and be able to attend school. They can get most, if not all, of their parenteral support when they're asleep. So, it makes a very, very big difference in the opportunity for the patient and the patient's entire community, which includes the physician, often nurses, nutritionists, and the family, all working together. Remember, every single day, these patients require parenteral nutrition. So, the groundbreaking results that we have already achieved in the intestinal-failure area were the results of an independent proof-of-concept study that was conducted with crofelemer in pediatric patients in UAE with intestinal failure due to microvillus inclusion disease for one patient and short bowel syndrome in two patients, and these were presented November 8 last year, 2025, at NASPGHAN, which is the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. This was presented by the study's primary investigator, Dr. Mohammed Miqdady, who has been a colleague and collaborator with the Company for many years, over about 8 years now. The initial results present and demonstrate disease-progression modification with crofelemer through reduction of parenteral support, the key endpoint that I mentioned in pediatric intestinal failure patients, and that reduction ranged from 12% to 37%. And remember, I said even 5% would be considered meaningful and what is meaningful means in terms of the vision, the viewpoint from regulatory agencies, FDA. Very specifically, the 2 pediatric short bowel syndrome intestinal failure patients who completed the treatment, the results show crofelemer reduced parenteral support between 12.5% and 15.6%. For the MVID patient, the parenteral support needs were reduced by up to 37%, and there have been no safety issues, which is consistent with the safety profile of crofelemer as demonstrated in thousands of patients in published clinical trials in other disorders and years of commercial availability of the drug at the FDA -- as the FDA-approved Mytesi for the HIV indication. We expect the patients participating in the ongoing trial in the UAE to be provided with crofelemer for the rest of their lives. Now, at this point, these patients have been treated for over a year. Initially, in the investigator-initiated trial protocol, they were treated for about 3 months with increasing doses. And then, again, no safety issues, they were taken off the drug, and very, very quickly in a matter of literally days, both the community, and the treating community, the parents and the physicians immediately needed to put the patients back on as there was a relapse situation, which is a very important indication of benefit when you're in a non-placebo-controlled situation. So, based on FDA support for a recently submitted protocol amendment for our placebo-controlled trial, which is fully enrolled for MVID, we will continue to evaluate the safety and efficacy of crofelemer. Now, this is crofelemer, but it's not Mytesi in terms of formulation. It's a highly concentrated liquid formulation that is appropriate for intestinal failure patients, as you can imagine, a pill would go right through them, and we're also talking about pediatric, in some cases, infants to be administered this product. In this trial, which, as I mentioned, is fully enrolled, the placebo-controlled trial, we filed amendment to allow the opportunity for patients to then go into a treatment-only extension phase. And again, it's expected that we would provide product for the rest of their lives. And this trial is taking place as often happens with rare diseases globally, so you can access the patients. So, in the United States, in Italy, and in the UAE, we're talking about an opportunity to complete our regulatory program and potentially file with continued response as we're seeing for a New Drug Application based on a single-digit number of patients. We also expect to be able to file for a Breakthrough designation from -- with the FDA, which is an opportunity to accelerate the U.S. regulatory path and potentially qualify for the European Medicines Agency, which is like the FDA of Europe, PRIME priority medicines, which can accelerate the regulatory path to approval and to market and commercialize and provide patient access in all 27 EU countries. As I mentioned, the target for the NDA with the FDA, the New Drug Application is in the first half of 2027, MVID against devastating, catastrophic, ultra-rare pediatric disorder; the estimated worldwide prevalence is about 200 patients. So, this trial of crofelemer in just a small number of patients is expected to be both statistically meaningful and remarkably meaningful, huge impact for the individual patients and be supportive of registration. There's no therapies available or even in clinical development for MVID other than life-saving parenteral support, again, lethal natural history and underscores the need for new therapies. We do have Orphan Designation in the U.S. and Europe for both MVID and short bowel syndrome. And not only does that provide the opportunity and the efficiency for a smaller number of patients, by the way, significantly lower cost, smaller number of patients in clinical trials, but also for a great deal of regulatory impact and communication as we're progressing through the program, and we absolutely have been taking advantage of that. As I mentioned, coincidentally, in time, we also have the intestinal-failure program enhanced by clinical proof-of-concept data in pediatric patients with intestinal failure due to short bowel syndrome. We have an ongoing randomized, double-blind, placebo-controlled Phase II study, again, of this highly concentrated liquid formulation of crofelemer in adult short bowel syndrome intestinal failure patients. Short bowel syndrome and the intestinal failure affects a significantly larger patient population than MVID, although still an orphan indication. And that arises from congenital anomalies, surgical resection due to Crohn's disease, cancer, accidents. Adult and pediatric patients with intestinal failure face chronic dependence on parenteral support due to the insufficient absorptive surface area of their intestine. So, unlike MVID, where the patient's intestine is completely intact, but not functioning, the intestinal-failure situation in short bowel syndrome patients is due to their short bowel. Our intestine, the normal one is typically 20, 25 feet. These could be 5 feet or less. So, there's simply not enough geography to absorb the nutrients of life. Patient population is estimated at about 12,000 patients in the United States in 2021, and this was from a third-party epidemiology study. We expect approval of crofelemer for MVID would support the development program for SBS-IF because the approval of MVID would likely help attract further partnering interest, since it's the same product. It's a different indication, but it would be the same product, safety, manufacturing. We get to benefit from the approval that we already have out there for Mytesi for crofelemer, although in a different formulation and then the efficacy. Very, very specifically, we're interested in a partner to assist in the funding for the final development and commercialization of crofelemer for MVID and short bowel syndrome IF, with commercialization efforts from the partner outside the United States, addressing the global need of this population. Drugs are, of course, approved based on manufacturing and safety, which I mentioned. Again, we get to leverage what we already have in place and the efficacy, safety, the benefit-risk ratio, with a risk of 0, the benefit -- any benefit that we can show, and continue to show based on our proof-of-concept data, can be infinity and beyond. We established our ability to perform and close on important non-dilutive business deals from where I started this presentation in January with the Future Pak deal. Again, $16 million non-dilutive dollars received upfront in January, another $2 million coming, $20 potential million throughout the course of the deal, over $3 million of which other dollars we have already received in this market. The IF market is considered to be 100x larger than the HIV market. With the clinical proof-of-concept data that we already have in hand, and near-term clinical and regulatory milestones ongoing from investigator-initiated trials, from presentations, publications from the ongoing placebo-controlled trials that we have, patients going into treatment-only extension phase, we are confident in our ability and our focus to execute upon our Business Development goals and strategy with our IF program, and further bring in the opportunity to further bring in non-dilutive dollars. I'll now hand the discussion over to Carol for her recap of the financial highlights that we released earlier this week for the third quarter of 2025. Over to you, Carol. Carol Lizak: Well, good morning, Lisa, and thank you all for joining our webcast today. I'll begin my review of our financials for the fourth quarter of 2025. The total net revenue for the Company's prescription products, Mytesi, Gelclair, and Canalevia-CA1 nonprescription products and license revenue was approximately $3.2 million in the fourth quarter of 2025, representing an increase of 5% over the total net revenue in the third quarter of 2025, which totaled approximately $3.1 million, and a decrease of approximately 8% over the total net revenue in the fourth quarter of 2024, which totaled approximately $3.5 million. In 2025, approximately $11.2 million out of the Company's total net revenue of $11.5 million was generated by sales of Mytesi and Canalevia-CA1. Under the terms of the license agreement, Jaguar entered with Future Pak in January 2026. Future Pak will be responsible for all commercial efforts and will receive all proceeds from the U.S. sales of Mytesi and Canalevia-CA1 as of January 12, 2026. Jaguar will be responsible for the supply of product at a premium price and will recognize manufacturing revenue. Future Pak has already purchased product from Jaguar in addition to paying $16 million to Jaguar of the upfront license fee and a $3 million payment. As we announced last month, the $3 million payment followed by Jaguar's termination of the buy-back provision of the Licensing Agreement we entered in January with Future Pak. This allows Future Pak to continue to commercialize Mytesi beyond 5 years. As Lisa mentioned, Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak, and the Licensing Agreement is in alignment with Jaguar's strategy to concentrate on crofelemer late-stage development efforts for human rare-disease intestinal failure indications. Mytesi prescription volume decreased approximately 3.7% in the year 2025 over 2024, by approximately 5.8% in the fourth quarter of 2025 over the third quarter of 2025, and by approximately 12.2% in the fourth quarter of 2025 over the same period last year. 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. Loss from operations increased by $15.1 million, from $30.8 million in the year ended December 31, 2024, to $45.9 million in 2025. Non-GAAP Recurring EBITDA for 2025 and 2024 were net loss of $48.1 million and $35.9 million, respectively. Net loss attributable to common shareholders increased by approximately $15.1 million, from $38.5 million in the year ended December 31, 2024, to $53.6 million in 2025. In addition to the loss from operations, the fair value of financial and hybrid instrument designation at Fair Value Option decreased by $3.2 million, from a loss of $9.5 million in the year ended December 31, 2024, to a loss of $6.3 million in 2025, primarily due to fair value adjustments in notes-payable designated at FVO or Fair Value Option. Loss on extinguishment of debt increased by $3 million, from a gain of $1.2 million in the year ended December 31, 2024, to a loss of $1.8 million in 2025, primarily due to substantial modifications to the expected payments of one royalty-interest agreement, which triggered extinguishment accounting. That concludes my recap of high-level financials to the fourth quarter of 2025. I will now hand the discussion back to Lisa. Lisa Conte: Thanks very much, Carol. Thanks, everyone, for listening. I do want to mention that while the Future Pak deal brings in, as I said, non-dilutive dollars and value to fuel, our rare-disease program, -- the value to Future Pak is very important in the HIV area, the addition of Mytesi to their portfolio. Last year, Future Pak bought Theratechnologies, which has 2 HIV programs -- 2 HIV products, excuse me, with a remarkable overlap in the targets, the physicians that are treating patients that would be expected to be experiencing GI disorder and HIV-related diarrhea. These are typically older patients, about 50% of patients living with HIV now in the United States are over the age of 50 have had the virus in their gut for over 10 years, often experiencing enteropathy and the inflammation that can lead to leaky gut and diarrhea. And they -- so they have a history, they have a product portfolio, and they have significantly greater commercialization capability than Jaguar. So Mytesi is in good hands in terms of getting to those patients with the unmet medical need and allowing us to focus on our next indications with important unmet medical need and disease, again, with a lethal natural history. So the opportunity to benefit immediate symptom-management, disease-progression modification, and potentially extension of the patient's life. Okay. We expect to provide clinical proof-of-concept milestones and Business Development discussions throughout the rest of this year and into 2027, with a very clear goal and focus to bring in non-dilutive funds from potential licensing partner or partners. We, at Jaguar, Napo, and Napo Therapeutics remain fully energized and excited about the multiple expected near-term catalysts for crofelemer and the Company, all of which we view as significant, value-enhancing, and potentially transformative for patients, and for the Company, and all the stakeholders in the company. Have a good day. This concludes our webcast for today, and we'll see you with the next quarter. Operator: Thank you. Ladies and gentlemen, this concludes today's Conference Call. You may disconnect your lines at this time. Thank you for your participation. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Jaguar (JAGX) Q4 2025 Earnings Transcript was originally published by The Motley Fool

Company Advances Towards Full FDA Approval of Crofelemer for Chemotherapy-Induced Diarrhea SAN FRANCISCO, CA / ACCESS Newswire / April 29, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced topline results from the completion of its effectiveness trial of crofelemer (FDA conditionally approved Canalevia-CA1) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. The statistically significant results demonstrated that dogs suffering from CID that were treated with Canalevia-CA1 twice daily at the onset of diarrhea had, at the end of 3 days of treatment, an average daily stool that is regarded as normal. Moreover, an owner's survey at the end of the study reported that 83% of owners indicate that Canalevia-CA1 was an effective treatment for their dog's CID. Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog's CID. In comparison, only 12.5% of owners reported they saw an improvement in their dog's CID without the use of any chemotherapy-induced diarrhea treatments. The Company expects to file the data from the complete analysis of this trial in support of full regulatory approval of crofelemer for CID and also submit for scientific publication. "We are quite pleased with the study results, supporting the paradigm shifting antisecretory mechanism of action of crofelemer in CID, typically a chloride ion mediated secretory diarrhea common across all mammals. Our vision at the company is to expand the opportunity to treat a broader collection of symptomatic diarrhea causes in companion animals with an anti-secretory approach," said Lisa Conte, Jaguar Founder and CEO. This study, "Clinical Field Study to Collect Real-World Data (RWD) to Demonstrate Real-World Evidence (RWE) of Effectiveness for Canaleviaﾮ-CA1 (Crofelemer delayed-release tablets) 125 mg for the Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs" is the pivotal study in substantiating treatment effectiveness in the upcoming Animal Drug application. Important Safety Information About Canaleviaﾮ-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 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 labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. 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. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome. For more information about: Jaguar Health, visit https://jaguar.health Napo Pharmaceuticals, visit www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." 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 a number of 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. View the original press release on ACCESS Newswire

This article first appeared on GuruFocus. Release Date: April 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Jaguar Health Inc (NASDAQ:JAGX) reported a 5% increase in net revenue for Q4 2025 compared to Q3 2025, reaching approximately $3.2 million. The company secured a transformative US out-license agreement with Future Pak for Mytesi, providing $18 million upfront, with $16 million already received. Jaguar Health Inc (NASDAQ:JAGX) continues to manufacture Crofelemer, turning it into a profit center by selling it to Future Pak. The company is in late-stage clinical development for rare disease intestinal failure indications, with promising data showing reduction in parenteral support needs by up to 37%. Jaguar Health Inc (NASDAQ:JAGX) aims to file a new drug application for MVID by 2027, targeting a market opportunity estimated at $8 billion by 2023. Total net revenue for Q4 2025 decreased by approximately 8% compared to Q4 2024. Loss from operations increased significantly by $15.1 million from 2024 to 2025. Net loss attributable to common shareholders rose by approximately $15.1 million from 2024 to 2025. Prescription volume for Mytesi decreased by approximately 12.2% in Q4 2025 compared to the same period last year. The company faces challenges in achieving regulatory approval for its new drug applications, with a target NDA filing not expected until 2027. Warning! GuruFocus has detected 8 Warning Signs with JAGX. Is JAGX fairly valued? Test your thesis with our free DCF calculator. Q: Can you elaborate on the significance of the US out-license agreement with Future Pak for Mytesi? A: Lisa Conte, President and CEO, explained that the agreement is transformative for Jaguar Health as it aligns with their strategy to focus on Crofelemer development for rare disease intestinal failure indications. The deal includes $18 million upfront, with $16 million already received, and potential milestone payments totaling $20 million. This provides nondilutive funding for their rare disease pipeline, turning Crofelemer into a profit center. Q: What are the key developments in Jaguar Health's rare disease intestinal failure program? A: Lisa Conte highlighted that they are in late-stage clinical development for conditions like Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome. They aim to file a new drug application by 2027. The market opportunity for Short Bowel Syndrome is estimated at $8 billion by 2023, significantly larger than the Mytesi HIV market. Q: How has the financial performance been for the fourth quarter of 2025? A: Carol Lizak, CFO, reported a 5% increase in net revenue to $3.2 million compared to the third quarter of 2025. However, there was an 8% decrease compared to the fourth quarter of 2024. The majority of revenue was generated by sales of Mytesi and Canalevia-CA1. Q: What are the expected impacts of the Future Pak deal on Jaguar Health's operations? A: Lisa Conte stated that Future Pak will handle all commercial efforts for Mytesi and Canalevia-CA1 in the US, allowing Jaguar to focus on manufacturing and development for rare diseases. This partnership is expected to enhance commercialization capabilities and provide Jaguar with nondilutive funding. Q: What are the future goals and strategies for Jaguar Health in 2026? A: Lisa Conte emphasized that the primary goal is to secure additional partnerships and nondilutive funding for their rare disease programs. They aim to achieve significant clinical and regulatory milestones, including filing for breakthrough designation with the FDA and potentially accelerating the regulatory path in Europe. For the complete transcript of the earnings call, please refer to the full earnings call transcript.