JAGX

Jaguar Health Inc

Topline results expected within a month and may complement positive results of a study of crofelemer for treatment of cancer therapy-induced diarrhea (CTD) in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI) SAN FRANCISCO, CA / ACCESS Newswire / April 8, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the Company has completed the company's ongoing effectiveness study of crofelemer delayed-release tablets for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Crofelemer, under the name Canalevia-CA1, is currently conditionally approved for the sole indication of treating CID in dogs. The approval for Canalevia CA-1 will expire on December 21, 2026. "We're very pleased that enrollment has concluded for this study, which is being undertaken at veterinary oncology clinics around the US. The FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID beyond Dec. 21, 2026, Jaguar must complete and file a successful effectiveness study," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. In the second quarter of 2026 Jaguar plans to submit and file the results of the company's effectiveness study and the positive results of a study of crofelemer delayed-release tablets for treatment of CTD in dogs receiving neratinib - a targeted tyrosine kinase inhibitor (TKI) chemotherapy agent. "The 28-day study in dogs receiving neratinib was designed to evaluate the scientific rationale for the use of crofelemer tablets in reducing the severity and incidence of diarrhea in cancer patients receiving neratinib, a targeted therapy known to cause significant diarrhea," said Dr. Guy "The study demonstrated that crofelemer dosing resulted in a 30% reduction in the incidence and severity of diarrhea in participating dogs, which was statistically significant." The results of the neratinib study were presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020 and published in the peer-reviewed journal PLOS ONE in January 2024. The study, titled Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs, was conducted by Jaguar family company Napo Pharmaceuticals in collaboration with Puma Biotechnology, Inc. and can be viewed by clicking here. Many cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in dogs and humans. A report by the American Veterinary Medical Association concluded that there were approximately 90 million dogs in the US in 2025, of which Jaguar estimates more than 11 million suffer from general diarrhea each year. Data from the European Pet Food Industry Federation concluded that there were approximately 90 million dogs in Europe in 2023. Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics. About Chemotherapy-induced Diarrhea (CID) in Dogs According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.1 According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US. Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,2 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID. Important Safety Information About Canalevia®-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 Canalevia-CA1, visit 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 submit an administrative NADA for crofelemer in the second quarter of 2026 that will include the results of the company's ongoing confirmatory study of crofelemer for treatment for CID in dogs and the results of the study of crofelemer for treatment of CID in dogs receiving neratinib. 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. 1 "Cancer in Pets." American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets 2 Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398 Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

Net revenue increase of 5% in Q4 2025 vs. Q3 2025 Jaguar received an up-front payment of $16Mof non-dilutive capital in January 2026 upon entering U.S. license agreement with Future Pak for Mytesi® and Canalevia®-CA1 - Jaguar's commercialized crofelemer drugs - with an additional $2 million due upon completion of post-closing conditions; and has received $3.0 of up to $20 million in milestone payments and other future payments Agreement with Future Pak is fully aligned with Jaguar's strategy to concentrate crofelemer development efforts on human rare-disease intestinal failure indications moving forward Jaguar will appeal Nasdaq's March 5, 2026 noncompliance determination related to Nasdaq Listing Rule 5550(a)(2) at a hearing on April 7, 2026; delisting is stayed pending the panel's final decision REMINDER: Friday, April 10, Jaguar to host investor webcast at 8:30 a.m. Eastern regarding Q4 2025 financials and company updates; Click here to register SAN FRANCISCO, CA / ACCESS Newswire / April 7, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated fourth-quarter 2025 financial results. 2025 FOURTH QUARTER COMPANY FINANCIAL RESULTS: Net Revenue: The total net revenue for the Company's prescription products (Mytesi®, Gelclair®, and Canalevia®-CA1), non-prescription 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 ("FP") in January 2026, FP 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 supply of product at a premium price and will recognize manufacturing revenue. FP has already purchased product from Jaguar, in addition to $16.0 mm of the up-front license fee and other $3.0 mm payment. The license 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: 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 fourth quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. License Revenue: For the fourth quarter of 2025, the Company recognized license fees of $42,500 from a securities purchase agreement with a European partner. As of December 31, 2025, the total deferred revenue associated with this contract amounts to approximately $552,000. Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the fourth quarters of 2025 and 2024. Cost of Product Revenue: Total cost of product revenue increased by $1.8 million, from $2.0 million for the year ended December 31, 2024 compared to about $3.8 million for the year ended December 31, 2025, due largely from a $2.0 million reserve related to adjusting inventory to its fair value at December 31, 2025. Research and Development: The R&D expense increased by $8.4 million, from $16.5 million for the year ended December 31, 2024 compared to approximately $25.0 million in 2025, primarily due to the clinical and manufacturing expenses associated with crofelemer lyophilization and clinical trial data charged to expenses, as they have no alternative future use. The remaining increase was attributable to the continued advancement of our clinical programs into later-stage development, resulting in higher clinical trial-related expenses and expanded contract manufacturing activities. Sales and Marketing: The Sales and Marketing expense increased by approximately $1.5 million, from $7.7 million for the year ended December 31, 2024 to approximately $9.2 million for the year ended December 31, 2025 largely due to personnel and related benefits related to the Gelclair sales team. General and Administrative: The G&A expense increased by approximately $2.3 million, from $16.3 million for the year ended December 31, 2024 to $18.6 million in 2025, largely due to increased legal and compliance expenses from Mytesi & Canalevia licensing to Woodward Specialty LLC, printing costs, investor relations, and financing activities. Impairment loss on indefinite-lived intangible assets: The Company recognized an impairment loss on intangible assets amounting to $0.8 million as a result of impairment evaluation to its in-process research and development ("IPR&D") triggered by delays in IBS and PEDS programs, resulting in a decline of the estimated fair values of IPR&D. There was no impairment loss recognized in 2024. Loss from Operations: 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. Net Loss: 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 ("FVO") 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. Loss on extinguishment of debt increased by $3.0 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. Year Ended Financial Highlights December 31, (in thousands, except per share amounts) 2025 2024 $ change % change Net product revenue $ 11,511 $ 11,689 (178 ) -1.5 % Loss from operations $ (45,908 ) $ (30,831 ) (15,077 ) 32.8 % Net loss attributable to common stockholders $ (53,575 ) $ (38,492 ) (15,083 ) 28.2 % Net loss per share, basic and diluted $ (24.27 ) $ (130.69 ) 106 Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for 2025 and 2024 were a net loss of $48.1 million and $35.9 million, respectively. Year Ended December 31, (in thousands) 2025 2024 $ change % change (unaudited) Net loss attributable to common stockholders $ (53,575 ) $ (38,492 ) 15,083 -39 % Adjustments: Interest income (expense) 67 231 164 71 % Property and equipment depreciation 62 67 5 7 % Amortization of intangible assets 1,851 1,834 (17 ) -1 % Share-based compensation expense 835 1,641 806 49 % Gain (loss) on extinguishment of debt 1,799 (1,245 ) (3,044 ) 244 % Impairment loss on indefinite-lived intangible assets 800 - 800 100 % Non-GAAP EBITDA (48,161 ) (35,964 ) 12,197 -34 % Note Regarding Use of Non-GAAP Measures The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP. The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition. Participation Instructions for Webcast When: Friday, April 10, 2026 at 8:30 a.m. Eastern Participant Registration & Access Link: Click Here Replay Instructions for Webcast Replay of the webcast on the investor relations section of Jaguar's website: (click here) About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. ("Jaguar") 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, 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 have a hearing on April 7, 2026 with the Nasdaq Hearings Department, and Jaguar's expectation that it will hold an investor webcast on April 10, 2026. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

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