Author: Jaguar Health, Inc.

• Jaguar has received the initial $16M payment related to the company’s recently executed US out-license agreement for Mytesi^® and Canalevia^®-CA1, which has the potential to provide Jaguar up to an additional $22M with milestones and other potential future payments

• Near-term milestones for intestinal failure program buttressed by groundbreaking results of parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients

• Associated with significant toxicities to patients, PS has a lethal natural history, and PS reduction can potentially extend and save lives

• Jaguar’s rare-disease pipeline is the subject of ongoing BD discussions with potential partners, targeting NDA-ready data in 12-18 months

• Jaguar presenting January 22 at Sequire Investor Summit in Puerto Rico; click here to register for event

• Click here to view replay of Jaguar’s January 15 fireside chat during Lytham Partners Healthcare Investor Summit

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:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

SAN FRANCISCO, CA / ACCESS Newswire / January 14, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company’s founder, president and CEO, will present virtually on Thursday, January 15, 2026 at the Lytham Partners Healthcare Investor Summit.

Participation Instructions for Jaguar’s Virtual Presentation at the Lytham Partners Healthcare Investor Summit

When: Thursday, January 15, 2026 at 3:30 PM Eastern

Registration link for conference: Click Here

Replay: A replay of the webcast will be available through the same link (Click Here)

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

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 conference listed above. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

SAN FRANCISCO, CA / ACCESS Newswire / January 14, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company’s founder, president and CEO, will present virtually on Thursday, January 15, 2026 at the Lytham Partners Healthcare Investor Summit.

Participation Instructions for Jaguar’s Virtual Presentation at the Lytham Partners Healthcare Investor Summit

When: Thursday, January 15, 2026 at 3:30 PM Eastern

Registration link for conference: Click Here

Replay: A replay of the webcast will be available through the same link (Click Here)

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

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 conference listed above. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

• $18M upfront payment to Jaguar ($16M upon deal closing and $2M upon completion of post-closing conditions)

• Up to additional $20M in milestone and other future payments

• Future Pak becomes exclusive U.S. marketer for Mytesi^® and Canalevia^®-CA1

• Jaguar continues to be the manufacturer of Mytesi and Canalevia-CA1

• Meaningful non-dilutive capital enables Jaguar to focus on its rare-disease pipeline, which is the subject of ongoing BD discussions with other potential partners

SAN FRANCISCO, CA / ACCESS Newswire / January 12, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that its wholly-owned subsidiary Napo Pharmaceuticals, Inc. (collectively, with Jaguar Health, Inc., “Jaguar”) has entered into a U.S. licensing agreement with an affiliate of privately held Future Pak, LLC (“Future Pak”). Under the terms of the agreement, Future Pak will be the exclusive marketer for Mytesi (crofelemer), Jaguar’s FDA-approved novel prescription drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy, and Canalevia-CA1, Jaguar’s crofelemer prescription drug for the treatment of chemotherapy-induced diarrhea in dogs. Jaguar will receive an $18 million upfront fee ($16 million at deal closing and $2 million upon completion of post-closing conditions) and up to $20 million in milestone payments and other future payments. Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak.

In September 2025, Future Pak acquired Theratechnologies Inc., a specialty biopharmaceutical company with two commercialized HIV medicines in the United States – EGRIFTA WR^™ (tesamorelin) and Trogarzo^® (ibalizumab-uiyk). “Jaguar’s license arrangement with Future Pak represents a strategic convergence for heightening awareness of Mytesi and the importance of supportive care for HIV long-term survivors – allowing the HIV community to benefit from the commercial capabilities of an organization with deep experience and a primary focus on the U.S. HIV market. Importantly, this agreement will provide Jaguar with meaningful non-dilutive capital while reducing the company’s operational complexity,” said Lisa Conte, founder, president, and CEO. “This agreement is fully aligned with our strategy to concentrate Jaguar’s crofelemer development efforts on human rare-disease indications, particularly intestinal failure, where we continue to advance business development discussions with additional potential partners.”

As stated above, the agreement also provides Future Pak with an exclusive license to Canalevai-CA1, Jaguar’s supportive care GI drug for dogs. Per the terms of the agreement, Jaguar has a 12-month right to reacquire Future Pak’s Mytesi and Canalevia-CA1 rights in the event of U.S. regulatory approval of mutually agreed-upon additional crofelemer indications in the same formulation as Mytesi after a specified period. This structure preserves Jaguar’s optionality as the company’s rare-disease pipeline progresses and benefits from Jaguar’s sharp strategic focus on rare disease indications for crofelemer over the next few years.

Crofelemer continues to advance as a potential treatment for rare forms of intestinal failure, including intestinal failure due to short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID). Multiple investigator-initiated and company-sponsored studies of crofelemer are ongoing in the U.S., the European Union and the United Arab Emirates, with initial proof-of-concept data showing significant reductions in parenteral support (PS) requirements in pediatric MVID and SBS-IF patients.

With continued demonstration of clinical benefit in Jaguar’s ongoing Phase 2 studies in MVID and SBS-IF, Jaguar hopes to achieve Breakthrough Therapy designation from the U.S. Food and Drug Administration for crofelemer for the treatment of MVID, and bring the product to market for this indication in the U.S. based on the study results expected in March 2026.

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 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.

About Future Pak

Founded in 1977 and headquartered in Wixom, Michigan, Future Pak, along with its affiliates, is a privately held contract manufacturer, packager and distributor of pharmaceutical and nutraceutical products. Future Pak operates across retail, specialty and institutional markets, leveraging its robust infrastructure and partner network to deliver quality-first, patient-centric solutions.

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

About Mytesi^®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling.Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

See full Prescribing Information at Canalevia.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that the agreement between Jaguar and Future Pak will reduce Jaguar’s operational complexity, Jaguar’s expectation that its rare-disease pipeline may progress and benefit from Jaguar’s sharp strategic focus on rare disease indications for crofelemer over the next few years, Jaguar’s expectation that, with continued demonstration of clinical benefit in its ongoing Phase 2 studies in MVID and SBS-IF, Jaguar may achieve Breakthrough Therapy designation from the U.S. Food and Drug Administration for crofelemer for the treatment of MVID and bring crofelemer to market for MVID in the U.S. based on the study results, and Jaguar’s expectation that the study results may be available in March 2026. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

• Article discusses results demonstrating parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients with intestinal failure

• Associated with significant toxicities to patients, PS has a lethal natural history, and PS reduction can potentially extend and save lives

SAN FRANCISCO, CA / ACCESS Newswire / January 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that an article published December 29, 2025 in HEALTH, a bi-monthly English and Arabic healthcare magazine in the United Arab Emirates, discusses the groundbreaking results of the ongoing and independent proof-of-concept study of crofelemer in pediatric patients in the UAE with intestinal failure due to the orphan diseases short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID). As announced, the initial results of this study 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 article can be viewed by clicking here.

The initial results of the proof-of-concept trial of crofelemer in the UAE demonstrate disease progression modification 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.

The intestines of patients with intestinal failure due to SBS-IF and MVID are unable to function like an intact gut. 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 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.

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.

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. 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, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities. The ability of crofelemer to decrease the volume of parenteral support in MVID patients is potentially life extending for these patients and is thus disease progression modifying.

In addition to supporting the ongoing crofelemer study in the UAE, Jaguar family company Napo Pharmaceuticals is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients at sites in the EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. 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.

Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS and MVID. In October 2025, as announced, the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for MVID.

About Crofelemer

Crofelemer is a novel, oral plant-based highly purified prescription medicine from the crude plant latex (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 (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 crofelemer may have the potential to extend and save the lives of patients with intestinal failure due to short bowel syndrome or MVID, and Jaguar’s expectation that an expedited approval pathway for crofelemer in the US may be possible. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar”) today announced that it received notice from the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) on January 1, 2026 that the company has been awarded a $240,000 grant. Canalevia-CA1 is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. The grant will support Jaguar’s ongoing study for the treatment of CID in dogs.

“As announced on December 10, 2025, the FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID, Jaguar must complete and file a successful effectiveness study,” said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar’s Vice President of Preclinical and Nonclinical Studies.

Dogs undergoing chemotherapy are an important predictive model for the mechanism of action in humans experiencing diarrhea due to cancer treatment. Many cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in dogs and humans.

A report by the American Veterinary Medical Foundation concluded that there were approximately 90 million dogs in the U.S. in 2024, of which Jaguar estimates more than 11 million suffer from general diarrhea each year. Data from the European Pet Food Industry Federation concluded that there were approximately 104 million dogs in Europe in 2022.

Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” 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 a number of 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.

¹ “Cancer in Pets.” American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar”) today announced that it received notice from the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) on January 1, 2026 that the company has been awarded a $240,000 grant. Canalevia-CA1 is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. The grant will support Jaguar’s ongoing study for the treatment of CID in dogs.

“As announced on December 10, 2025, the FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID, Jaguar must complete and file a successful effectiveness study,” said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar’s Vice President of Preclinical and Nonclinical Studies.

Dogs undergoing chemotherapy are an important predictive model for the mechanism of action in humans experiencing diarrhea due to cancer treatment. Many cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in dogs and humans.

A report by the American Veterinary Medical Foundation concluded that there were approximately 90 million dogs in the U.S. in 2024, of which Jaguar estimates more than 11 million suffer from general diarrhea each year. Data from the European Pet Food Industry Federation concluded that there were approximately 104 million dogs in Europe in 2022.

Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” 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 a number of 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.

¹ “Cancer in Pets.” American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

SBS-IF is the second orphan disease target indication for Jaguar’s intestinal failure program, which includes microvillus inclusion disease (MVID) – for which the company completed a meeting in October 2025 with the FDA in support of a possible expedited approval pathway

SAN FRANCISCO, CA / ACCESS Newswire / December 15, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals‘ (Napo’s) independent investigator at a leading SBS-IF treatment institution submitted an abstract describing preliminary findings from a clinical trial evaluating a novel oral liquid formulation of crofelemer in adult SBS-IF patients. This abstract is for consideration for presentation at the May 2-5, 2026 Digestive Disease Week^® conference. The submission supports Jaguar’s strategic focus on intestinal failure in adult short bowel syndrome patients, where reducing dependence on parenteral support remains a critical unmet need. An overview of the study can be viewed on the ClinicalTrials.gov website. SBS-IF is the second orphan disease target indication for Jaguar’s intestinal failure program, which includes the ultrarare genetic disorder microvillus inclusion disease (MVID). In October 2025 the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for MVID.

“Findings from independent investigator-initiated studies provide proof-of-concept data and continue to build the evidence supporting crofelemer’s ability to reduce stool and stomal output and the drug’s potential to reduce parenteral support needs in patients with intestinal failure – a core focus of the company for treating rare and orphan GI disorders,” said Lisa Conte, Jaguar’s founder, president, and CEO.

The intestines of patients with intestinal failure due to short bowel syndrome are unable to function like an intact gut, a similar situation to that in patients with intestinal failure due to MVID. 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, and as presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial results of the ongoing and independent proof-of-concept trial of crofelemer in the United Arab Emirates demonstrate disease progression modification through reduction of 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 support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients.

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. 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, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities.

In addition to supporting the ongoing IIT at this US institution, Napo is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients at sites in the EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. 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.

Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS and MVID.

About Crofelemer

Crofelemer is a novel, oral plant-based highly purified prescription medicine from the crude plant latex (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 (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 an expedited approval pathway for crofelemer in the US may be possible. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

• CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs enrolled to date; ~49 more expected

SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, the company’s prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy. The renewal of conditional approval is in effect until December 21, 2026.

“Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID. We’re very pleased about this conditional approval renewal, which, per FDA regulations, is for the fifth and final allowable year of conditional approval for Canalevia-CA1 for the CID indication in dogs. When an animal drug receives conditional approval, the FDA requires that a confirmatory trial take place within 5 years to provide the substantial evidence of effectiveness required for full approval of the drug for the indication,” said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar’s Vice President of Preclinical and Nonclinical Studies. “As announced, our full effectiveness study of Canalevia-CA1 for the treatment of CID in dogs is underway, and this recent conditional approval renewal was granted because we were able to demonstrate active progress toward generating this required data.”

“Diarrhea is a highly neglected and unmet medical need in dogs and people undergoing cancer treatment,” said Lisa Conte, Jaguar’s president and CEO. “Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment.”

About Conditional Approval and Full Approval

Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA’s conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the “substantial evidence” standard of effectiveness for full approval. The conditional approval is valid for one year, with up to four annual renewals, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving “substantial evidence of effectiveness” for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug.

About Canalevia^®-CA1

Canalevia-CA1 contains crofelemer, Jaguar’s novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, that modulates chloride channels in the gastrointestinal tract to reduce diarrhea. Importantly, Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics. Canalevia-CA1, currently conditionally approved by the FDA under application number 141-552, is a tablet that can be given orally twice a day for up to three days and can be used for home treatment of CID in dogs.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that the company’s ongoing trial will provide the substantial evidence of effectiveness required for full approval of the drug for treatment of CID in dogs and will conclude in February 2026 with an approximate total of 100 dogs having participated. 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 a number of 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.

¹ “Cancer in Pets.” American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Jaguar CEO Lisa Conte presenting December 10 from 3:25pm – 3:35pm Eastern at the Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID

Company completed meeting with FDA October 2, 2025 for advice on advancing its ongoing placebo-controlled trial of crofelemer in support of possible expedited approval pathway for crofelemer for treatment of MVID

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the voting results of the Company’s Special Meeting of Stockholders held on December 8, 2025 (the “Special Meeting”).

Three proposals were submitted to and approved by the stockholders of the Company at the Special Meeting. The proposals are described in detail in the Company’s definitive proxy statement on Schedule 14A relating to the Special Meeting filed with the Securities and Exchange Commission on November 10, 2025. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company’s corporate website.

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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

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 December 2025 Emerging Growth Conference, Jaguar’s expectation that crofelemer can potentially extend the lives of infants born with intestinal failure due to MVID, reducing the volume of PS necessary for them to survive, and Jaguar’s expectation that an expedited approval pathway may be possible for crofelemer for treatment of MVID. 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:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire