Jaguar Health (JAGX) Emerging Growth Conference 93 summary

Key business and financial developments

• Licensed U.S. commercial rights for Mytesi and Canalevia, securing up to $38 million in non-dilutive funding, with $16 million received upfront and additional milestone payments underway.

• Strategic focus shifted to rare disease pipeline, particularly intestinal failure, leveraging new funding for clinical and regulatory catalysts expected over the next 12 months.

• Manufacturing of crofelemer remains in-house, benefiting from economies of scale and profitability.

• Out-licensed Canalevia to Future Pak, with recent confirmatory study supporting transition from conditional to full approval for broader veterinary use.

• Magdalena Biosciences joint venture mobilizes plant library for CNS indications, funded externally, with no financial burden to the company.

Product pipeline and clinical progress

• Crofelemer, a plant-based, FDA-approved drug, is the only oral product approved under botanical guidance for HIV-related diarrhea and chemotherapy-induced diarrhea in dogs.

• Rare disease program targets intestinal failure, focusing on MVID (ultra-rare pediatric) and short bowel syndrome, using a new highly concentrated liquid formulation.

• Proof-of-concept data show up to 37% reduction in parenteral support for MVID patients and 16% for short bowel syndrome, with additional benefits in stool volume, diarrhea, and urine output.

• Regulatory filings for new drug application in MVID expected by end of year, with breakthrough designation filing planned for Q3/Q4 and SBS adult trial ongoing.

• Orphan drug designation granted in U.S. and Europe for both MVID and short bowel syndrome indications.

Market opportunity and strategic positioning

• Intestinal failure market is estimated to be 10x larger than the HIV Mytesi market, with rare disease pricing flexibility and potential for blockbuster revenues exceeding $1 billion.

• GATTEX, a competing product for short bowel syndrome, is reimbursed at $500,000/year in the U.S., highlighting strong precedent for high-value rare disease therapies.

• Oncology market for crofelemer is significant due to the prevalence of diarrhea in patients on targeted therapies, but further development requires a partner.

• Company plans to seek additional non-dilutive partnerships for commercialization, especially in the U.S., after achieving key clinical milestones.