Jaguar Health, Inc. (JAGX) has announced a net revenue of approximately $3.1 million for the third quarter of 2024, marking a 14% increase from the previous quarter and an 11% increase from the same period last year. This growth is attributed to increased prescription volume for Mytesi. The company is also progressing with the development of crofelemer for cancer therapy-related diarrhea and rare diseases.
OnTarget Trial Results
Significant results from the Phase III OnTarget trial in breast cancer patients have been accepted for a poster presentation at the San Antonio Breast Cancer Symposium on December 11, 2024. While the trial did not meet its primary endpoint for all solid tumor types, meaningful clinical signals were observed in breast cancer and lung cancer patients. A second late-breaking abstract related to the OnTarget trial, based on data from the placebo arm, has also been accepted for a poster presentation.
Lisa Conte, Founder, President, and CEO of Jaguar Health, stated, "We did achieve meaningful clinical signals in breast cancer...patients." The company plans to engage with the FDA in 2025 regarding regulatory pathways for crofelemer in breast cancer patients.
Gelclair Launch
Jaguar Health has launched Gelclair, an FDA-approved oral mucositis prescription product, in the United States. Oral mucositis is a common and painful side effect of cancer treatment, affecting up to 40% of patients treated with chemotherapy. Gelclair is designed to manage and relieve pain by adhering to the mucosal surface of the mouth, providing a protective coating that soothes and supports healing.
Crofelemer for Rare Diseases
Crofelemer is also being developed for rare and orphan diseases, including microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF). Two Phase II trials are planned for the fourth quarter of this year, with multiple investigator-initiated proof-of-concept studies underway in the United States, Europe, and the MENA regions. The company has orphan drug designation for crofelemer in both the United States and Europe for MVID and SBS-IF.
Pravin Chaturvedi, Chief Scientific Officer, explained that a novel, highly concentrated lyophilized crofelemer powder for oral solution formulation has been developed for SBS-IF patients. This formulation aims to reduce stool volume output and the requirements for total parenteral support (TPN).
Financial Highlights
The company's total net revenue for Mytesi and Canalevia-CA1 prescription products, nonprescription products, and license revenue was approximately $3.1 million in Q3 2024, an increase of approximately 14% versus Q2 2024. Mytesi prescription volume increased by 10.9% in Q3 2024 compared to Q2 2024.
Carol Lizak, CFO of Jaguar Health, noted that the net loss from operations decreased by $1.5 million, from $8.8 million in Q3 2023 to $7.3 million in Q3 2024.
Future Outlook
Jaguar Health anticipates significant catalysts in the next six months, including the development of crofelemer for cancer therapy-related diarrhea and the commercial launch of Gelclair. The Board of Directors has no intention of implementing a reverse split of the company's common stock. The company is also focusing on increasing institutional investor interest.
