Jaguar Health, Inc. Q2 FY2024 earnings call

Clinical Trials and Pipeline - The OnTarget Phase III trial observed meaningful clinical signals in breast and lung cancer patients receiving targeted therapies. Pravin discussed responder analysis in the trial, noting clinically important signals in these subgroups despite small sample sizes. - Crofelemer continues to show benefit in various gastrointestinal indications, with ongoing analyses of data from the OnTarget trial, including the extension phase. - For rare diseases, crofelemer has orphan drug designation for SBS-IF and MVID. Plans include investigator-initiated trials in these areas, with an import permit granted for Abu Dhabi to conduct a proof-of-concept trial. ### Gelclair Launch - Cathy Collis discussed the planned October 2024 commercial launch of Gelclair, an FDA-approved oral mucositis product. Focus is on head and neck cancer patients, with efforts to educate patients and healthcare professionals, including exhibiting at oncology conferences and a strong digital component. ### Financial Recap - Carol Lizak provided a recap of financial highlights, including revenue figures and changes in loss from operations and net loss attributable to common shareholders.

Jaguar Health's combined net second quarter 2024 revenue was approximately $2.72 million for prescription and non-prescription products. This represents a 16% increase versus net Q1 2024 revenue of $2.350 million and a 2% increase versus net Q2 2023 revenue of $2.67 million. Mytesi prescription volume increased by 5.2% in Q2 2024 compared to Q1 2024, and decreased slightly by 0.4% compared to the same period in 2023. Loss from operations decreased by $0.9 million from $8.1 million in Q2 2023 to $7.2 million in Q2 2024. Non-GAAP recurring EBITDA for Q2 2024 was a net loss of $8.8 million, compared to a net loss of $7.7 million in Q2 2023. Net loss attributable to common shareholders decreased by approximately $2.6 million from $12.1 million in Q2 2023 to $9.5 million in Q2 2024.

- Continued analysis of the OnTarget trial data, including responder analysis for various subgroups and the extension phase, with plans to potentially reveal statistically significant results in 2025. - Anticipation of the proof-of-concept results for rare disease trials in Q4 2024. - Upcoming commercial launch of Gelclair in October 2024, with a strategic focus on head and neck cancer patients.

- Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. - Complexities in analyzing data from the OnTarget trial, including statistical rules for censoring data, handling missing data, and addressing intercurrent events. - Regulatory uncertainties in expanding the label for crofelemer and conducting trials for rare diseases.

Q: Could you elaborate on the clinical signals in breast and lung cancer patients from the OnTarget trial?

A: Pravin explained that responder analysis showed 79% of crofelemer group patients in breast and lung cancer subgroups achieved less than or equal to 7 watery stools per week, compared to 68% in the placebo group, with clinically important differences despite small sample sizes.

Q: What are the plans for the Gelclair commercial launch?

A: Cathy Collis stated the focus is on head and neck cancer patients, with efforts to educate through exhibitions at oncology conferences and a strong digital component, with the launch scheduled for October 2024.