Jaguar Health (JAGX) investor relations material

Strategic partnerships and licensing

• Entered an exclusive license agreement with FuturePak, potentially worth up to $38 million, including $16 million upfront and $20 million in commercial milestones.

• FuturePak, through Theratechnologies, will now commercialize Mytesi and Canalevia-CA1, allowing a focus on R&D and pipeline development.

• Manufacturing of crofelemer remains in-house, turning it into a profit center.

• Business development opportunities remain for blockbuster indications and international animal health markets.

Pipeline and clinical development

• Focus shifted to rare disease programs, especially MVID and short bowel syndrome, with clinical trials ongoing.

• MVID program may allow for FDA filing by end of this year, with potential approval in 2026 based on single-digit patient trials.

• Proof-of-concept data showed up to 39% reduction in parenteral support for MVID and 12-15% for SBS, supporting breakthrough and prime designations.

• Short bowel syndrome market estimated at $5–12 billion, with limited competition and high unmet need.

• Key milestones include completion of MVID and SBS trials, regulatory filings, and business development deals in 2026.

Regulatory and commercial highlights

• Mytesi is the only FDA-approved oral botanical drug for chronic diarrhea in HIV/AIDS and has exclusivity due to botanical guidance.

• Canalevia-CA1 received renewed conditional FDA approval for chemotherapy-induced diarrhea in dogs, with a full approval study underway.

• Breakthrough and prime designations could accelerate regulatory timelines in the US and EU for rare disease indications.

• Investigator-initiated trials and international collaborations are expanding clinical evidence and global reach.

• Milestone payments from FuturePak and expanded commercial resources are expected to drive revenue growth.