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

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) received an initial $16M payment from a US out-license of Mytesi and Canalevia-CA1, with up to $22M more tied to milestones. The company is refocusing on crofelemer for intestinal failure (SBS-IF and MVID), holding Orphan Drug Designation in the US and EU. Investigator-initiated proof-of-concept results showed parenteral support (PS) reductions of 12–37% in pediatric patients. Jaguar expects its placebo-controlled Phase 2 to complete in Q2 2026 and targets NDA-ready data in 12–18 months. Management presented at the Sequire Investor Summit on January 22, 2026.

Positive

• $16M initial non-dilutive payment received
• Up to $22M additional milestone payments possible
• PS reduced 12–37% in pediatric proof-of-concept
• Orphan Drug Designation granted in US and EU
• Phase 2 expected to complete in Q2 2026

Negative

• Initial proof-of-concept data from only three completed pediatric patients
• MVID prevalence is tiny: estimated 100–200 patients worldwide
• Up to $22M additional payments are contingent on milestones

News Market Reaction

-9.78%

15 alerts

-9.78% News Effect

+23.0% Peak Tracked

-11.2% Trough Tracked

-$432K Valuation Impact

$4M Market Cap

0.4x Rel. Volume

On the day this news was published, JAGX declined 9.78%, reflecting a notable negative market reaction. Argus tracked a peak move of +23.0% during that session. Argus tracked a trough of -11.2% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $432K from the company's valuation, bringing the market cap to $4M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Initial license payment: $16M Additional potential payments: $22M PS reduction range: 12–37% +5 more

8 metrics

Initial license payment $16M Initial payment from U.S. out-license for Mytesi and Canalevia-CA1

Additional potential payments $22M Milestones and other potential future payments from license deal

PS reduction range 12–37% Parenteral support reduction in pediatric intestinal failure proof-of-concept

SBS-IF PS reduction 12.5–15.6% PS reduction in two pediatric SBS-IF patients over 12 weeks at highest dose

MVID PS reduction (12 weeks) 27% PS reduction in initial pediatric MVID patient over 12 weeks at highest dose

MVID PS reduction (extension) 37% PS reduction during extension period after crofelemer reinitiation

SBS prevalence US 10,000–20,000 patients Estimated U.S. short bowel syndrome patient population

Global SBS market $7.93 billion Estimated global short bowel syndrome market size by 2033

Market Reality Check

Price: $0.6700 Vol: Volume 2,128,947 is about...

low vol

$0.6700 Last Close

Volume Volume 2,128,947 is about 0.21x the 20-day average 10,299,373, indicating muted trading interest pre‑announcement. low

Technical Shares at 0.8091 are trading below the 200-day MA of 2.97 and sit 96.86% under the 52-week high, despite being 26.4% above the 52-week low.

Peers on Argus

JAGX was down 5.37% while close peers showed mixed moves: QNRX -3.67%, AZTR -4.7...

1 Up 1 Down

JAGX was down 5.37% while close peers showed mixed moves: QNRX -3.67%, AZTR -4.73%, ONCO -8.57% versus XRTX +2.47% and GRI +1.36%. Momentum data show only one peer (GRI -13.50%) moving down alongside JAGX, with another (TOVX) up 4.12%, supporting a stock‑specific reaction.

Historical Context

5 past events · Latest: Jan 14 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	Investor conference	Positive	+10.6%	Virtual Lytham investor summit presentation update on near-term catalysts.
Jan 12	License agreement	Positive	-20.9%	U.S. license deal for Mytesi and Canalevia with up to $38M economics.
Jan 06	Clinical data update	Positive	+9.7%	UAE pediatric intestinal failure proof-of-concept data highlighting PS reduction.
Jan 02	FDA grant/vet drug	Positive	+7.1%	FDA grant and renewed conditional approval for Canalevia-CA1 in dogs.
Dec 15	Trial abstract news	Positive	-11.8%	Abstract submission with preliminary adult SBS-IF crofelemer data.

Pattern Detected

Recent Jaguar news skewed positive in tone, with 3 of 5 events seeing supportive price moves and 2 showing sharp negative divergences, particularly around financing and licensing structures.

Recent Company History

Over the past six weeks, Jaguar reported several catalysts spanning financing, licensing, clinical data, and investor outreach. On Dec 15, 2025, it highlighted preliminary SBS-IF data and an expedited FDA pathway discussion, followed by an $240,000 FDA grant and conditional approval renewal on Jan 2, 2026. Subsequent UAE intestinal failure data and a U.S. license deal with Future Pak led to mixed share reactions. The current update extends this rare-disease narrative, emphasizing non-dilutive funding and advancing crofelemer toward regulatory filings.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-03

The company has an effective S-3 shelf filed on 2025-10-03, expiring on 2028-10-03, with at least one recorded usage via a 424B3 on 2025-11-25. The filing details prior private placements, warrants, and preferred stock structures tied to the crofelemer franchise.

Market Pulse Summary

The stock moved -9.8% in the session following this news. A negative reaction despite clearly positi...

Analysis

The stock moved -9.8% in the session following this news. A negative reaction despite clearly positive clinical signals fits Jaguar’s mixed history, where good news occasionally coincided with selloffs, as seen after the January 12 license agreement. The market may have focused on the company’s low share price relative to its 52-week high, prior use of notes and warrants, and overall risk profile, even as non-dilutive funds and PS reductions up to 37% strengthened the rare-disease thesis around crofelemer.

Key Terms

parenteral support, total parenteral nutrition, orphan drug designation, new drug application, +4 more

8 terms

parenteral support medical

"groundbreaking results of parenteral support (PS) reduction ranging from 12 to 37%"

Parenteral support is medical care that delivers nutrition, fluids or medications directly into a patient’s bloodstream or body tissues, bypassing the digestive system—think of it as feeding or hydrating someone through an IV rather than by mouth. Investors care because this service involves specialized products, durable revenue from long-term patient use, strict safety and reimbursement rules, and potential regulatory or supply risks that affect company earnings and growth.

total parenteral nutrition medical

"consists of total parenteral nutrition (TPN) with supplemental intravenous fluids"

Total parenteral nutrition is a medical treatment that supplies all needed calories, fluids, vitamins and minerals directly into a patient’s bloodstream through an IV, bypassing the digestive tract — like a complete meal delivered by a drip. It matters to investors because TPN relies on specialized ingredients, preparation and delivery services with steady hospital and home-care demand, significant regulation and reimbursement exposure, and potential for durable revenue or risk from supply-chain or clinical issues.

orphan drug designation regulatory

"The company has received Orphan Drug Designation for both diseases for crofelemer"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

new drug application regulatory

"following the filing of an NDA (New Drug Application) with the U.S. Food and Drug"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

breakthrough therapy designation regulatory

"Jaguar hopes to achieve Breakthrough Therapy designation from the FDA for crofelemer"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

european medicines agency regulatory

"qualify crofelemer for the European Medicines Agency's (EMA) PRIME (priority medicines)"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

investigator-initiated trial medical

"initial results of the investigator-initiated trial (IIT) of crofelemer in the UAE"

A clinical study led and managed by an independent researcher or physician rather than the company that makes the drug or device; the investigator designs the protocol, runs the study at their site(s), and often controls the data even if the company supplies the product or funding. For investors, these trials can produce important third‑party validation or new uses for a product — like an independent test drive revealing strengths or limits — and their outcomes can change a product’s commercial and regulatory prospects.

placebo-controlled medical

"ongoing placebo-controlled Phase 2 clinical trial of crofelemer in pediatric MVID"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. Not financial advice.

• 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

FAQ

What payment did Jaguar Health (JAGX) receive from the Mytesi US out-license on January 22, 2026?

Jaguar received an initial $16M payment, with up to $22M in potential milestone payments.

What parenteral support (PS) reductions did crofelemer show in Jaguar's pediatric proof-of-concept study?

Investigator-reported results showed PS reductions ranging from 12% to 37% across treated pediatric patients.

When does Jaguar expect its crofelemer Phase 2 trial to complete and when could NDA-ready data be available for JAGX?

The placebo-controlled Phase 2 is expected to complete in Q2 2026, with NDA-ready data targeted in 12–18 months.

Does crofelemer have regulatory incentives for intestinal failure indications for JAGX?

Yes; crofelemer has received Orphan Drug Designation in both the US and EU for SBS and MVID.

How large is the patient population for MVID relevant to Jaguar (JAGX) forecasts?

MVID is ultrarare, with an estimated worldwide prevalence of about 100–200 patients.

Are Jaguar's additional milestone payments guaranteed following the Mytesi out-license?

No; the additional $22M in payments are contingent on achieving specified milestones.