Release Date: November 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Jaguar Health Inc (NASDAQ:JAGX) reported a 4% increase in net revenue for Q3 2024 compared to Q2 2024, and an 11% increase compared to Q3 2023.
• The company achieved significant results in a phase three trial for breast cancer patients, with data accepted for presentation at a major cancer symposium.
• Jaguar Health Inc (NASDAQ:JAGX) launched its third commercialized prescription product, GelClear, in the U.S., targeting oral mucositis, a common cancer treatment side effect.
• The company is initiating multiple clinical trials for rare and orphan diseases, with potential early patient access programs in Europe.
• Jaguar Health Inc (NASDAQ:JAGX) has orphan drug designation for its product in both the U.S. and Europe, which could support early patient access before full regulatory approval.

Negative Points

• The company reported a net loss attributable to common shareholders of $9.9 million for Q3 2024, an increase from $7.8 million in Q3 2023.
• Jaguar Health Inc (NASDAQ:JAGX) did not achieve the primary endpoint for all solid tumor types in its ambitious phase three trial.
• The company's discussions with the FDA cannot be fast-tracked, potentially delaying regulatory approval processes.
• Despite increased revenue, the company still faces significant operational losses, with a GAAP recurring EBITA net loss of $9.2 million for Q3 2024.
• The company acknowledges the high cost and risk associated with clinical development, particularly for its late-stage products.

Q & A Highlights

• Warning! GuruFocus has detected 7 Warning Signs with JAGX.

Q: Are you looking to partner with the right company to enhance the pipeline? Are you looking into institutional investors? A: Lisa Conte, CEO: Absolutely, we are looking to institutional investors. We have great liquidity in the stock, which attracts institutional investors. We are introducing the story to institutional investors globally. Regarding partnerships, we have global unencumbered rights to Proflo and existing partnerships in Turkey and Eastern Europe. We are always open to business development discussions for potential partnerships to bring in non-dilutive dollars.

Q: Can you explain the extension data from the 12 weeks in the on-target trial? A: Dr. Pravin Credi, Chief Scientific Officer: We are focused on the placebo-controlled blinded first 12-week stage of the study. We have collected data for patients who continued into another 12-week period. We will evaluate this data after completing the stage one analysis. The emphasis will be on the responder analysis of the first 12 weeks, but we will also consider signals from the second stage for the breast cancer subgroup.

Q: Can discussions with the FDA be fast-tracked? A: Dr. Pravin Credi, Chief Scientific Officer: No, the FDA operates on a first-in, first-out basis and prioritizes based on unmet need and impact. While they can give fast-track or breakthrough designations to development plans, the timing of meetings cannot be expedited.

Q: What is the company's approach to achieving profitability in the biotech sector? A: Lisa Conte, CEO: Mytesi for HIV is a positive contributor to profitability. GelClear, recently launched, aims for a positive contribution soon. The focus is on major unmet needs like mucositis and cancer therapy-related diarrhea, with efforts in late-stage clinical development to minimize risk. The investment in these areas aims for significant impact on patients and stakeholders.

Q: What are the key financial highlights for the third quarter of 2024? A: Carol Isaac, CFO: Total net revenue was approximately $3.1 million, a 14% increase from the second quarter of 2024 and an 11% increase from the third quarter of 2023. Mytesi prescription volume increased by 10.9% compared to the second quarter of 2024. Net loss from operations decreased by $1.5 million compared to the same period in 2023.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.