The Albany Gazette - Jaguar Health Highlights Sharp Strategic Focus on Rare Intestinal Failure Diseases Fueled by Non-Dilutive Funds from Closing of License Deal for Mytesi

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 22, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today provided updates regarding the company's strategic focus on its rare disease development program for crofelemer, which is focused on near-term milestones for the treatment of intestinal failure in patients with short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID). The company has received Orphan Drug Designation for both diseases for crofelemer in the US and EU. This development effort is being fueled by the non-dilutive funds received from the recent closing of an out-license agreement for the US rights to commercialize Mytesi and Canalevai-CA1, and is a potential blockbuster opportunity for all Jaguar stakeholders, including patients.

"As we were pleased to announce last week, Jaguar is now focusing first and foremost on our ongoing global development program for our powder-for-oral-solution formulation of crofelemer for intestinal failure - a program that is the subject of business development discussions with potential partners and gives us the opportunity to potentially bring crofelemer to market next year following the filing of an NDA (New Drug Application) with the U.S. Food and Drug Administration (FDA) for crofelemer for our lead target indication, MVID," said Lisa Conte, founder, president, and CEO. "Crofelemer has demonstrated groundbreaking benefit in pediatric patients - demonstrating reductions in parenteral support (PS), which has a lethal natural history - in this patient population. The safety of locally acting crofelemer continues to be a hallmark of the drug and a critical factor in assessing the benefit / risk for intestinal failure patients."

Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Many intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, and liver and kidney function problems. These symptoms may emerge at any time in intestinal failure patients and often become life-threatening.

As announced, the groundbreaking initial results of the ongoing and independent proof-of-concept study of crofelemer in pediatric patients in the United Arab Emirates (UAE) with intestinal failure due to MVID and short bowel syndrome were presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting by the study's primary investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City, a tertiary care center in Abu Dhabi in the UAE. The initial results demonstrate disease progression modification with crofelemer through reduction of parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in two pediatric SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and showed reduced frequency of loose watery stools. These findings are important because PS treatment has a lethal natural history, and crofelemer can potentially extend and save the lives of patients by reducing the volume of PS.

With continued demonstration of clinical benefit in Jaguar's ongoing placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID patients, which is expected to complete in the second quarter of 2026, and because MVID is an ultrarare disease for which no approved treatments currently exist, Jaguar hopes to achieve Breakthrough Therapy designation from the FDA for crofelemer to accelerate the US regulatory path to market for MVID and qualify crofelemer for the European Medicines Agency's (EMA) PRIME (priority medicines) program for MVID to accelerate the regulatory path to market in all 27 EU countries. "That's how unprecedented and paradigm-shifting crofelemer's mechanism of action and the initial results are in intestinal failure patients with MVID," said Conte. "MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of only 100-200 patients, so a trial of crofelemer in just a small number of MVID patients is expected to be statistically meaningful and support registration."

In light of the initial results of the investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of MVID and in support of Jaguar's efforts to make crofelemer available to children with MVID as quickly and efficiently as possible, as announced, the company met with the FDA on October 2, 2025 to seek their advice regarding Jaguar's ongoing clinical trial of crofelemer for MVID treatment. Based on the feedback from the FDA during this meeting, as announced, the company submitted an amended protocol to the FDA in November 2025 for its ongoing placebo-controlled clinical trial of crofelemer in pediatric MVID patients. Jaguar has also filed a request to allow patients who complete the blinded phase of the study to continue on crofelemer treatment, as has been requested by the study investigator. Jaguar's expectation is that the amended protocol, along with the results of this study, if positive, will support a faster FDA review and approval of crofelemer for MVID.

Crofelemer has been granted Orphan Drug Designation by the FDA and the EMA for SBS and MVID. Short bowel syndrome (SBS) affects approximately 10,000 to 20,000 people in the US, according to the Crohn's & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size. A report by DataM Intelligence estimates that the size of the global short bowel syndrome market will reach $7.93 billion by 2033. MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child. MVID has a lethal natural history along with significant co-morbidities.

The UAE has a significantly high prevalence of congenital disorders (birth defects) and genetic conditions, due to the frequency of consanguineous marriage. Many Arab countries display some of the highest rates of consanguineous marriages in the world, ranging around 20-50% of all marriages.

In addition to running the company's ongoing placebo-controlled Phase 2 clinical trial of crofelemer for MVID at sites in the US, EU, and Middle East and supporting the ongoing independent crofelemer study in the UAE, Jaguar family company Napo Pharmaceuticals is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients and supporting a US IIT of crofelemer in adult SBS-IF patients. The company is also supporting evaluation of crofelemer powder for oral solution in expanded access programs to treat intestinal failure in pediatric patients with MVID in the US.

Participation Instructions for Jaguar's In-Person Presentation at the Sequire Investor Summit

When: Thursday, January 22, 2026 from 10:30 AM to 11:00 AM Eastern, Main Stage-Track 2

Where: Condado Vanderbilt Hotel, San Juan, Puerto Rico

Registration link for conference: Click Here

About Crofelemer

Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the January 2026 Sequire Investor Summit, Jaguar's expectation that its recently executed US out-license agreement for Mytesi and Canalevia-CA1 may provide Jaguar up to an additional $22M with milestones and other potential future payments, Jaguar's expectation that the opportunity may exist to bring crofelemer to market in 2027 for MVID following the filing of an NDA with the FDA for crofelemer for MVID, Jaguar's expectation that crofelemer has the potential to extend and save the lives of intestinal failure patients by reducing the volume of PS, Jaguar's expectation that its placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID patients will complete in the second quarter of 2026, Jaguar's expectation that the company may be granted Breakthrough Therapy designation from the FDA for MVID and PRIME designation from the EMA for MVID, Jaguar's expectation that the amended protocol it submitted to the FDA for the company's placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID patients, along with the results of this study, if positive, may support faster FDA review and approval of crofelemer for MVID, and the third-party estimate that the size of the global short bowel syndrome market will reach $7.93 billion by 2033. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Source: Jaguar Health, Inc.

Contact:

[email protected]

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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