Jaguar Health Enters into U.S. License Agreement with Future Pak for Crofelemer, Providing up to $38 Million

Rhea-AI Summary

Jaguar Health (NASDAQ: JAGX) entered a U.S. license agreement with Future Pak on January 12, 2026, granting Future Pak exclusive U.S. marketing rights for Mytesi (crofelemer) and Canalevia-CA1 while Jaguar will remain the manufacturer.

Jaguar will receive an $18 million upfront payment ($16M at closing, $2M on post-closing conditions) and is eligible for up to $20 million in milestone and other future payments. The agreement includes a 12-month Jaguar right to reacquire rights for mutually agreed additional crofelemer indications upon U.S. regulatory approval. Jaguar said the deal provides non-dilutive capital to focus crofelemer development on rare-disease indications, with Phase 2 study results for MVID expected in March 2026.

Positive

• Upfront non-dilutive cash of $18 million
• Potential $20 million in milestone and future payments
• Exclusive U.S. marketing by Future Pak with HIV-commercial experience
• Jaguar retains manufacturing and a 12-month reacquisition right

Negative

• U.S. commercial rights licensed away, reducing Jaguar's direct commercial upside
• Significant portion of future value tied to uncertain milestone payments
• Upcoming Phase 2 readout in March 2026 creates near-term clinical binary risk

News Market Reaction

-20.95% 143.9x vol

51 alerts

-20.95% News Effect

+20.7% Peak Tracked

-47.1% Trough Tracked

-$1M Valuation Impact

$4M Market Cap

143.9x Rel. Volume

On the day this news was published, JAGX declined 20.95%, reflecting a significant negative market reaction. Argus tracked a peak move of +20.7% during that session. Argus tracked a trough of -47.1% from its starting point during tracking. Our momentum scanner triggered 51 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $4M at that time. Trading volume was exceptionally heavy at 143.9x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Upfront payment: $18M Closing tranche: $16M Post‑closing tranche: $2M +5 more

8 metrics

Upfront payment $18M License fee to Jaguar; $16M at closing, $2M post‑closing conditions

Closing tranche $16M Portion of upfront payment due at deal closing

Post‑closing tranche $2M Upfront amount upon completion of post‑closing conditions

Milestone & future payments Up to $20M Additional potential payments under the Future Pak license

Total deal potential Up to $38M Combined upfront, milestone, and other future payments

Reacquisition right window 12 months Jaguar’s right to reacquire Mytesi and Canalevia‑CA1 U.S. rights

PS frequency Up to 7 days/week Parenteral support burden for some intestinal failure patients

PS duration 20 hours per day Potential daily duration of parenteral support in severe cases

Market Reality Check

Price: $0.5858 Vol: Volume 179,386 is in line...

normal vol

$0.5858 Last Close

Volume Volume 179,386 is in line with activity, at 0.92x the 20-day average of 195,292. normal

Technical Shares at 1.05 are trading below the 200-day MA of 3.11, reflecting a longer-term downtrend.

Peers on Argus

Pre‑news, JAGX was down 2.78% while momentum peers like AZTR and GRI were up abo...

2 Up 1 Down

Pre‑news, JAGX was down 2.78% while momentum peers like AZTR and GRI were up about 6–7%. Despite scanner data flagging sector strength, JAGX’s decline diverged from peers, pointing to more stock‑specific trading rather than a pure sector rotation.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Clinical data update	Positive	+9.7%	Highlighted UAE proof‑of‑concept crofelemer results in pediatric intestinal failure.
Jan 02	FDA grant/support	Positive	+7.1%	Announced <b>$240,000</b> FDA grant and renewed conditional approval for Canalevia‑CA1.
Dec 15	Trial abstract news	Positive	-11.8%	Reported SBS‑IF abstract submission and reiterated encouraging PS‑reduction data.
Dec 10	Approval renewal	Positive	+13.7%	FDA renewed conditional approval for Canalevia‑CA1 through <b>Dec 21, 2026</b>.
Dec 08	Corporate governance	Positive	+1.9%	Stockholders approved all meeting proposals and company highlighted MVID progress.

Pattern Detected

Recent fundamentally positive updates on crofelemer and Canalevia have more often coincided with upward price reactions, though there is at least one notable divergence on favorable trial‑related news.

Recent Company History

Over the past month, Jaguar has issued multiple updates centered on crofelemer and its supportive‑care franchises. On Dec 8, 2025, shareholders approved all proposals while early MVID data and FDA interactions were highlighted. Subsequent December releases detailed conditional approval renewal and trial progress for Canalevia‑CA1, plus new SBS‑IF data and an abstract submission. In early January 2026, Jaguar emphasized UAE intestinal‑failure proof‑of‑concept results and secured a $240,000 FDA grant. Today’s U.S. license deal fits the pattern of monetizing commercial assets while advancing rare‑disease development.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-03

Jaguar has an effective S-3 shelf filed on 2025-10-03, expiring 2028-10-03. It has been used at least once, as indicated by the 424B3 filed on 2025-11-25, giving the company flexibility to register and resell securities as needed.

Market Pulse Summary

The stock dropped -20.9% in the session following this news. A negative reaction despite this cash‑g...

Analysis

The stock dropped -20.9% in the session following this news. A negative reaction despite this cash‑generating license could fit a pattern where investors focus on balance sheet structure and prior financings rather than single transactions. The deal’s up to $18M upfront and up to $20M in additional payments offers non‑dilutive capital, yet an effective S-3 shelf, royalty obligations, and past exchange transactions remain part of the story, creating risk that concerns over future financings overshadow operational progress.

Key Terms

fda-approved, chemotherapy-induced diarrhea, phase 2, breakthrough therapy designation, +4 more

8 terms

fda-approved regulatory

"Mytesi (crofelemer), Jaguar's FDA-approved novel prescription drug"

FDA-approved means a medical product, drug, device or treatment has passed the U.S. Food and Drug Administration’s review for safety and effectiveness for a specific use. Think of it like a formal safety and performance seal that allows the product to be marketed for that purpose in the U.S.; for investors, approval reduces regulatory uncertainty, enables sales and reimbursement pathways, and can materially affect a company’s revenue prospects and valuation.

chemotherapy-induced diarrhea medical

"for the treatment of chemotherapy-induced diarrhea in dogs"

Chemotherapy-induced diarrhea is a common side effect of cancer drugs where patients experience frequent, loose bowel movements that can be severe enough to require medical care or dose changes. It matters to investors because it affects patient quality of life, can force treatment delays or lower drug use, and creates demand for supportive therapies or label warnings — similar to how a recurring maintenance problem can reduce a car’s reliability and sales.

phase 2 medical

"With continued demonstration of clinical benefit in Jaguar's ongoing Phase 2 studies"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

breakthrough therapy designation regulatory

"hopes to achieve Breakthrough Therapy designation from the U.S. Food and Drug Administration"

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.

u.s. food and drug administration regulatory

"designation from the U.S. Food and Drug Administration for crofelemer"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

parenteral support medical

"showing significant reductions in parenteral support (PS) requirements"

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 (tpn) medical

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

Total parenteral nutrition (TPN) is a medical treatment that delivers all essential nutrients—calories, protein, electrolytes, vitamins and fluids—directly into a patient’s bloodstream through a vein when they cannot eat or digest food. Investors care because TPN drives revenue and costs across hospitals, specialty pharmacies, device makers and drug suppliers; changes in patient demand, safety issues, regulatory rules or reimbursement can materially affect sales, margins and supply chains, similar to how fuel shipments matter to transportation companies.

intravenous administration medical

"often requires patients to receive life-sustaining fluids ... through intravenous administration"

Intravenous administration is delivering a drug or fluid directly into a vein using a needle or tube, so the substance enters the bloodstream immediately. For investors, it matters because this route gives faster, more predictable effects and often higher costs, special equipment or clinical procedures, which can affect a therapy’s safety profile, regulatory approval path, pricing, and how easily it can be used outside hospitals — all factors that influence market potential.

AI-generated analysis. Not financial advice.

• $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

FAQ

What are the financial terms of Jaguar Health's January 12, 2026 license with Future Pak (JAGX)?

Jaguar received an $18 million upfront payment ($16M at closing, $2M on post-closing conditions) and is eligible for up to $20 million in milestone and other future payments.

Which products does Future Pak get U.S. rights to under the JAGX deal?

Future Pak becomes the exclusive U.S. marketer for Mytesi (crofelemer) and Canalevia-CA1 under the license agreement.

Will Jaguar Health still manufacture Mytesi after the license (JAGX)?

Yes. Jaguar will continue to manufacture Mytesi and Canalevia-CA1 for Future Pak.

Does Jaguar have any option to regain marketed rights for crofelemer (JAGX)?

Yes. Jaguar has a 12-month right to reacquire Future Pak's Mytesi and Canalevia-CA1 rights if mutually agreed additional crofelemer indications receive U.S. regulatory approval.

How does the JAGX deal affect Jaguar's drug development priorities?

The agreement provides non-dilutive capital allowing Jaguar to concentrate crofelemer development on rare-disease indications such as MVID and SBS-IF.

When does Jaguar expect key clinical data that could affect crofelemer's regulatory path (JAGX)?

Jaguar expects Phase 2 study results in March 2026 that it says could support a Breakthrough Therapy designation for MVID if beneficial.