Jaguar Health (JAGX) investor relations material

Transformation and strategic focus

• Transitioned to a rare disease-focused strategy, emphasizing plant-based prescription medicines for gastrointestinal disorders.

• Achieved a transformative out-license deal for Mytesi and Canalevia-CA1, securing $18 million upfront and future milestone payments.

• Maintains manufacturing control of crofelemer, supporting scale and follow-on indications.

• Over 150 patents provide long-term exclusivity, minimizing risk of generic competition.

• Strategic focus is now on rare disease programs, especially intestinal failure indications.

Clinical pipeline and milestones

• Crofelemer is being developed for rare intestinal failure diseases, including MVID and short bowel syndrome, with proof-of-concept and pivotal data available.

• Expecting final clinical data for MVID by end of 2026, aiming for NDA filing in first half of 2027 and potential US approval by end of 2027.

• Blinded phase II trial for short bowel syndrome is nearing completion, aligning with MVID NDA timeline.

• Breakthrough designation filing targeted for Q4 this year, potentially expediting regulatory review.

• Global trials are ongoing, with significant activity in Europe and the UAE.

Market opportunity and competitive landscape

• Intestinal failure market, including MVID and SBS, estimated at over $8 billion.

• Crofelemer offers a differentiated, highly concentrated liquid formulation for intestinal failure, distinct from Mytesi's pill form.

• GLP-2 is the only approved competitor for SBS but has significant limitations and side effects; crofelemer aims to become standard of care.

• Orphan designation secured for key indications, supporting premium pricing and reimbursement.

• European market is a major value driver, typically six months behind US in reimbursement.