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SAN FRANCISCO - Jaguar Health, Inc. (NASDAQ:JAGX) announced Monday that enrollment in its placebo-controlled Phase 2 study of crofelemer for pediatric microvillus inclusion disease (MVID) has reached approximately 25%, with patient screening continuing. The company, which generated revenue of $11.55 million in the last twelve months with an impressive 82.34% gross profit margin, continues to advance its clinical programs despite challenging market conditions. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value calculations.
The company also reported that initial results from an ongoing investigator-initiated trial (IIT) in Abu Dhabi showed crofelemer reduced required total parenteral nutrition (TPN) by up to 27% in MVID patients and up to 12.5% in short bowel syndrome patients. Data from a third patient in this trial is expected.
Jaguar's Phase 2 study for short bowel syndrome in adults has surpassed 10% enrollment. The company expects to complete its pediatric MVID study by mid-2026.
"Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products - with the goal of generating non-dilutive funding for Jaguar," said Lisa Conte, Jaguar's Founder and CEO. With a total debt of $38.34 million and rapid cash burn rate, this strategic focus on non-dilutive funding appears crucial. InvestingPro subscribers can access 14 additional key insights about Jaguar Health's financial health and market position.
Crofelemer is a plant-based prescription medicine derived from the Croton lechleri tree in the Amazon Rainforest. The drug's mechanism of action may provide a therapeutic option to reduce TPN and associated complications in patients with intestinal failure.
MVID is an ultrarare pediatric disease characterized by severe diarrhea and malabsorption requiring intensive parenteral support for nutritional and fluid management. Currently, no approved drug treatments exist for this condition. For detailed analysis of Jaguar Health's market potential and comprehensive financial metrics, investors can access the full Pro Research Report available on InvestingPro, which covers over 1,400 US stocks with expert insights and actionable intelligence.
According to the company's press release statement, the initial proof-of-concept data may support crofelemer's inclusion in expedited regulatory approval pathways in both the EU and US.
In other recent news, Jaguar Health has reported a challenging first quarter of 2025, with net revenue falling to $2.2 million, a 6% decrease compared to the same period last year. The company also announced a $1.5 million direct offering, involving the sale of common stock and warrants, with H.C. Wainwright & Co. as the exclusive placement agent. Additionally, Jaguar Health is seeking FDA orphan drug designation for crofelemer, aimed at treating cancer therapy-related diarrhea in metastatic breast cancer patients, following significant findings in a subgroup of a Phase 3 trial. The company is also planning to initiate an expanded access program for patients not eligible for the anticipated pivotal treatment trial. Jaguar Health's Q1 2025 results showed an increase in operational losses to $9.4 million, indicating ongoing financial challenges. Despite this, prescription volume for Mytesi, a drug for HIV-related diarrhea, saw a slight increase. The company continues to focus on developing plant-based treatments for rare diseases, with ongoing trials and potential regulatory pathways for crofelemer. These developments come amid a backdrop of strategic efforts to secure non-dilutive funding and business development opportunities.
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