Jaguar Animal Health (NASDAQ:JAGX) said its second-quarter strategy centers on advancing crofelemer, a powder-for-oral-solution formulation being studied for rare intestinal failure disorders, following the January licensing of its U.S. Mytesi business to Future Pak.
Founder, President and Chief Executive Officer Lisa Conte said the company received an $18 million upfront payment under the Future Pak agreement, including a $16 million payment at closing and a subsequently released $2 million holdback. Jaguar also may receive up to $17 million in additional milestone payments. Future Pak became the exclusive U.S. marketer of Mytesi, an FDA-approved tablet formulation of crofelemer for adults with HIV/AIDS and diarrhea, and Canalevia-CA1, a conditionally approved treatment for chemotherapy-induced diarrhea in dogs.
Focus on intestinal failure indications
The company’s lead target is pediatric microvillous inclusion disease, or MVID, an ultra-rare congenital condition that can cause severe diarrhea and inability to absorb nutrients. Patients may require parenteral support, including intravenous nutrition and fluids, for as much as 20 hours per day, Conte said.
Jaguar is studying an oral liquid formulation of crofelemer designed to reduce fluid loss and potentially lower patients’ dependence on parenteral support. The product is distinct from the Mytesi tablet, Conte said, because a tablet may not be suitable for intestinal-failure patients with rapid intestinal transit.
At the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition meeting in June, Jaguar presented results from orally treated pediatric intestinal-failure patients. According to Conte, parenteral-support requirements normalized to body weight declined by up to 48% in one MVID patient after more than 12 months of treatment and by up to 40% in two patients with short bowel syndrome and intestinal failure, or SBS-IF.
Conte said patients experienced relapse after being taken off crofelemer under the study protocol and subsequently resumed treatment. She also said the company has not observed crofelemer-related safety issues in its intestinal-failure patients.
- Jaguar’s randomized, double-blind, placebo-controlled MVID trial is fully enrolled, with sites in the U.S., Italy and the United Arab Emirates.
- The FDA authorized a treatment-only extension phase following the blinded portion of the trial, and the first MVID patients have entered that phase.
- The company expects its clinical package for MVID to be ready by the end of 2026 and plans to submit a new drug application in the latter part of the second quarter of 2027.
- Jaguar expects to have sufficient treatment-extension data by the fourth quarter of 2026 to seek FDA breakthrough therapy designation.
Conte said that, if breakthrough therapy designation is granted, an NDA could potentially receive a review of approximately four months. The company said it could potentially receive U.S. approval for MVID by the end of 2027, while a European timeline would likely extend into 2028.
Short bowel syndrome program
Jaguar is also conducting a Phase II randomized, double-blind, placebo-controlled study of the same liquid crofelemer formulation in adults with SBS-IF at sites in Germany and Italy. The company expects results from that trial around the time of its planned MVID NDA submission in mid-2027.
Conte said the MVID program could establish manufacturing and safety groundwork for a later SBS-IF approval pathway. The company has orphan-drug designations for both MVID and SBS in the U.S. and Europe.
Management cited third-party market estimates projecting the global SBS-IF market could reach approximately $8 billion in 2033, while the global MVID market could exceed $1 billion. These estimates and potential development-partner opportunities were presented as part of Jaguar’s rationale for pursuing a licensing or commercialization partner for the rare-disease program.
Second-quarter financial results
Chief Financial Officer Carol Lizak reported prescription-product net revenue of approximately $1.2 million for the second quarter of 2026, primarily from Mytesi sales to Future Pak. Revenue was about 2% lower than the first quarter and 60% below the approximately $2.9 million reported in the second quarter of 2025.
Lizak said the year-over-year revenue change reflected the Future Pak licensing arrangement, under which U.S. revenues from Mytesi and Canalevia-CA1 are directed to Future Pak. She said Mytesi bottle sales increased significantly from the year-earlier period while commercial costs declined substantially.
Loss from operations narrowed to approximately $7.6 million from $8 million a year earlier, as a $2.1 million reduction in operating expenses more than offset a $1.7 million decrease in product revenue. Non-GAAP recurring EBITDA was a loss of approximately $8.4 million, compared with a loss of $7.9 million in the prior-year quarter.
Net loss attributable to common shareholders widened to approximately $12.7 million from $10.4 million. Lizak attributed the increase in part to higher interest expense, fair-value adjustments to liability-classified warrants and notes, and a larger loss on debt extinguishment.
Separately, Jaguar said it is preparing for a near-term launch of Neonorm Dog, a nonprescription, plant-based product intended to support stool consistency and gastrointestinal fluid balance in dogs. The company said it expects the product to be available through online and animal-health retail channels, including Amazon and Chewy.
About Jaguar Animal Health (NASDAQ:JAGX)
Jaguar Animal Health, Inc is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the gastrointestinal health of food-producing animals, with an emphasis on swine and poultry. The company’s research and development efforts target common enteric disorders such as post-weaning diarrhea in pigs and clostridial overgrowth in broiler chickens, aiming to provide effective alternatives to traditional antibiotic treatments.
Jaguar Animal Health was formed in early 2019 through the acquisition of the animal health business of Aratana Therapeutics by Actinium Animal Health, followed by a corporate rebranding.
