Jaguar Health (JAGX) Lytham Partners Fall 2024 Investor Conference summary

Key clinical and regulatory developments

• Announced crofelemer achieved statistical significance in a pre-specified subgroup of breast cancer patients in the OnTarget phase III trial for cancer therapy-related diarrhea.

• Data forms the basis for an FDA briefing package, aiming to expand crofelemer's use to cancer patients, especially those with breast cancer.

• Five clinical efforts are advancing in rare diseases, including short bowel syndrome and MVID, with three investigator-initiated and two global phase II trials starting in Q4 2024.

• IND approved for a second-generation GI agent for cholera and severe diarrheas; three novel psychoactive botanical drug candidates are IND-ready for 2025.

• Additional analyses and publications from the OnTarget trial are planned, with ongoing patient-reported outcomes and further subgroup reviews.

Commercial and financial highlights

• Launching third FDA-sanctioned product, GelClair, for oral mucositis in October 2024, marking entry into cancer supportive care.

• Q2 net revenue increased 16% over Q1, driven by HIV-related diarrhea product sales; further growth expected with GelClair revenues.

• High-volume stock with significant clinical and regulatory catalysts anticipated in Q4 2024.

• Market opportunities include $3B for chemotherapy-induced nausea/vomiting and $5B for short bowel syndrome, with crofelemer positioned as a paradigm-shifting therapy.

• Napo Therapeutics, 90% owned, focuses on rare diseases and early patient access in Europe.

Product differentiation and patient impact

• Crofelemer is plant-based, sustainably harvested, FDA-approved, and the only oral drug under botanical guidance, offering practical exclusivity.

• Acts locally in the gut, avoiding systemic absorption, drug-drug interactions, and antibiotic resistance; not an opioid, with a safety profile similar to placebo.

• Addresses major unmet needs in cancer therapy-related diarrhea, improving patient quality of life and therapy adherence.

• GelClair provides muco-adhesion for pain relief and healing in oral mucositis, reducing reliance on opioids and improving patient outcomes.

• Patient advocacy and digital campaigns emphasize the patient voice in clinical development and regulatory engagement.