Jaguar Health (JAGX) investor relations material

Key catalysts and inflection points

• Recent and upcoming catalysts include FDA meetings, orphan drug applications, and new clinical data releases for crofelemer in cancer and rare diseases.

• Crofelemer is FDA-approved for HIV-related chronic diarrhea and conditionally approved for chemotherapy-induced diarrhea in dogs.

• Statistically significant results were achieved in breast cancer patients, leading to an orphan drug application for metastatic breast cancer.

• Four phase 2 studies are ongoing in intestinal failure, with groundbreaking reductions in parenteral support for MVID and short bowel syndrome.

• Expanded access programs and supplemental NDA filings are planned to expedite patient access.

Product pipeline and market opportunities

• Crofelemer is positioned as a pipeline within a product, targeting multiple indications in both human and animal health.

• The cancer therapy-related diarrhea market is analogous to the $4B chemotherapy-induced nausea market, with long-term therapy needs.

• Short bowel syndrome represents a $4.5B market opportunity, with orphan designations in the US and Europe.

• The veterinary market provides valuable commercialization insights and potential cross-market promotional support.

• Business development efforts focus on non-dilutive partnerships, leveraging de-risked programs for larger deals.

Clinical and regulatory progress

• Phase 3 trial in cancer therapy-related diarrhea completed; focus shifted to metastatic breast cancer for expedited approval.

• Orphan drug application filed for metastatic breast cancer, with a treatment trial including all metastatic patients expected to complete in 2026.

• Investigator-initiated trials in MVID and short bowel syndrome show unprecedented reductions in parenteral nutrition needs.

• Upcoming FDA meetings aim to expedite approval for ultra-rare diseases with small patient populations.

• Continued data presentations at major medical conferences are planned.