Jaguar Health (JAGX) Investor update summary

Strategic transformation and business focus

• Completed a transformative out-license agreement for Mytesi with Future Pak, securing $18 million upfront and up to $17 million in future milestones, enabling a sharp focus on rare disease GI programs.

• Shifted all human development efforts to rare disease indications, specifically targeting intestinal failure with orphan drug designation in the US and Europe.

• Actively seeking a development and commercialization partner for the rare disease program, leveraging recent high-value industry deals as benchmarks.

Clinical development and milestones

• Lead indication is pediatric microvillous inclusion disease (MVID), an ultra-rare disorder with no approved therapies and a lethal natural history.

• Presented data showing crofelemer reduced parenteral support by up to 48% in MVID and 40% in SBS-IF patients, far exceeding the clinically relevant threshold of 10%-15%.

• No crofelemer-related safety issues reported; ongoing blinded, placebo-controlled trials in MVID and SBS-IF are fully enrolled.

• NDA submission for MVID targeted for Q2 2027, with potential US approval by end of 2027 if breakthrough therapy designation is granted.

Market opportunity and competitive landscape

• Intestinal failure market estimated at $8 billion by 2033, with MVID alone valued over $1 billion; both have orphan drug status.

• Crofelemer offers a first-in-class, non-growth hormone, anti-secretory mechanism, potentially becoming standard of care for MVID and SBS.

• GLP-2 therapies, the only approved competitor for SBS, have significant limitations and are not standard of care.