STOCK TITAN

Jaguar Health (NASDAQ: JAGX) sees 48% IV nutrition cut, plans NDA filing

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Jaguar Health, Inc. (JAGX) reported second quarter 2026 results and highlighted progress in its global development program for crofelemer targeting rare intestinal failure (IF) diseases. A key update was presentation of additional data at ESPGHAN 2026 on crofelemer as adjunctive oral therapy for pediatric IF, including ultrarare microvillus inclusion disease (MVID). The data showed a reduction of parenteral support normalized to body weight of up to 48% in a patient with MVID. Jaguar stated it expects the clinical package for a New Drug Application (NDA) for MVID to be ready by the end of 2026, with NDA submission planned for the second quarter of 2027.

Positive

  • Up to 48% reduction in parenteral support in an MVID patient on crofelemer adjunctive therapy was reported, and Jaguar expects its clinical package for an MVID NDA by end of 2026 with planned NDA submission in Q2 2027.

Negative

  • None.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Reduction in parenteral support up to 48% Reported in a pediatric patient with microvillus inclusion disease (MVID) on crofelemer adjunctive therapy
NDA clinical package timing for MVID end of 2026 Expected timing for completion of clinical package for MVID NDA
Planned NDA submission for MVID Q2 2027 Planned submission timing for an NDA for MVID
Press release date August 19, 2026 Date of Jaguar Health’s press release reporting Q2 2026 results
New Drug Application regulatory
"company expects clinical package for NDA for MVID to be ready"
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.
microvillus inclusion disease (MVID) medical
"in patient with the ultrarare microvillus inclusion disease (MVID)"
A rare, inherited disorder that appears in infants when cells lining the small intestine lack tiny hair‑like structures (microvilli), so the gut cannot absorb fluids and nutrients; this causes severe, life‑threatening diarrhea and often requires long‑term intravenous nutrition or other intensive care. For investors, MVID signals a clear unmet medical need that can make treatments, diagnostics or medical devices attractive targets for drug developers, diagnostic labs and specialty biotech firms because of potential regulatory incentives and high per‑patient value despite a small patient population.
parenteral support medical
"demonstrate reduction of parenteral support normalized to body weight"
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.
intestinal failure (IF) medical
"global development program for crofelemer for rare intestinal failure (IF) diseases"
adjunctive oral therapy medical
"evaluation of crofelemer as adjunctive oral therapy for the treatment of pediatric IF"
Offering Type other

FAQ

What did Jaguar Health (JAGX) announce in its second quarter 2026 8-K?

Jaguar Health announced second quarter 2026 results and emphasized progress in its crofelemer program for rare intestinal failure diseases. It highlighted new pediatric MVID data and outlined a timeline targeting an MVID NDA clinical package by end of 2026 and filing in Q2 2027.

What new crofelemer clinical data did Jaguar Health (JAGX) present for MVID?

Jaguar Health reported pediatric MVID data showing crofelemer adjunctive oral therapy produced up to a 48% reduction in parenteral support normalized to body weight for a patient. These data were presented at ESPGHAN 2026 as part of its intestinal failure development program.

What is Jaguar Health’s (JAGX) NDA timeline for microvillus inclusion disease?

Jaguar Health expects its clinical package for an NDA for microvillus inclusion disease (MVID) to be ready by the end of 2026. The company plans to submit this NDA in the second quarter of 2027, subject to ongoing development progress.

Which disease areas is Jaguar Health (JAGX) focusing on with crofelemer?

Jaguar Health remains focused on a global development program for crofelemer in rare intestinal failure (IF) diseases. This includes pediatric IF indications such as ultrarare microvillus inclusion disease (MVID), where it reported new data on reduced parenteral support requirements.

Was detailed financial information for JAGX’s Q2 2026 results included here?

The company stated that it released second quarter 2026 financial results via a press release furnished as Exhibit 99.1. The information summarized here focuses on the crofelemer development program and MVID clinical and regulatory timeline rather than specific financial figures.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001585608 0001585608 2026-08-19 2026-08-19
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 19, 2026

 

 

Jaguar Health, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-36714   46-2956775

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

200 Pine Street

Suite 400

 
San Francisco, California   94104
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (415) 371-8300

 

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, Par Value $0.0001 Per Share   JAGX   The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02

Results of Operations and Financial Condition.

On August 19, 2026, Jaguar Health, Inc. (the “Company”) issued a press release announcing the second quarter 2026 results. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 and the press release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, or incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

   Description
99.1    Press Release, dated August 19, 2026.
104    Cover Page Interactive Data File (embedded within the inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      JAGUAR HEALTH, INC.
Date: August 19, 2026     By:  

/s/ Lisa A. Conte

     

Lisa A. Conte

Chief Executive Officer & President

Exhibit 99.1

 

LOGO

Jaguar Health Reports Second Quarter 2026 Financials

Company remains sharply focused on its ongoing global development program for crofelemer for rare intestinal failure (IF) diseases; as announced, presentation at ESPGHAN 2026 described additional groundbreaking results of evaluation of crofelemer as adjunctive oral therapy for the treatment of pediatric IF, which demonstrate reduction of parenteral support normalized to body weight of up to 48% in patient with the ultrarare microvillus inclusion disease (MVID); company expects clinical package for NDA for MVID to be ready by end of 2026, allowing submission of NDA in Q2 2027

REMINDER: Jaguar to host investor webcast Wednesday, August 19 at 4:30 p.m. Eastern regarding Q2 2026 financials and company updates (click here to register)

SAN FRANCISCO, CA / August 19, 2026 / Jaguar Health, Inc. (NASDAQ: JAGX) (“Jaguar” or the “Company”) today reported its consolidated second-quarter 2026 financial results.

2026 SECOND QUARTER COMPANY FINANCIAL RESULTS:

 

   

License and Grant Revenue: Effective January 12, 2026, Jaguar entered a U.S. commercial licensing agreement with Woodward Specialty, LLC (“Woodward”), an affiliate of privately held Future Pak, LLC (“Future Pak”). Under the terms of the agreement, Future Pak is now the exclusive U.S. marketer for the Company’s Mytesi® and Canalevia®-CA1 products. License revenues for the initial $16 million upfront payment, in addition to the $3 million payment for early termination of the Buy-Back Option under this agreement, were recognized by the Company in the first quarter of 2026. As announced in August 2026, Jaguar has satisfied the closing conditions required to receive payment of the non-dilutive $2 million holdback amount of the upfront fee from Future Pak. Napo remains the manufacturer of crofelemer and Mytesi and supplies product to Future Pak at cost-plus terms. Additionally, the Company recognized license fees of $43,000 in the second quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of June 30, 2026, the total deferred revenue associated with this contract amounts to $468,000. Federal grant revenue recognized in the second quarter of 2026 for the clinical study related to the treatment of chemotherapy-induced diarrhea (“CID”) in dogs was $25,520 and none in 2025.

 

   

Prescription Product Revenue, Net: The total net revenue for the Company’s prescription products (Mytesi, Gelclair, and Canalevia-CA1) was approximately $1.2 million in the second quarter of 2026, which was compromised primally of sales of Mytesi at cost-plus to Future Pak. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1, effective from January 12, 2026, are directed to Future Pak. Future Pak is privately held and does not report Mytesi sales. Compared to the second quarter of 2025, the number of Mytesi bottles the Company sold in the second quarter of 2026 increased significantly and commercial costs were substantially decreased. The decision to enter a commercial license agreement with Future Pak aligns with Jaguar’s strategic focus on advancing the development of its powder-for-oral-solution formulation of crofelemer for rare-disease indications related to intestinal failure in humans. The total net revenue for the Company’s prescription products in the second quarter of 2026 represents a decrease of approximately 2% compared to the first quarter of 2026, when total net revenue for prescription products was approximately $1.2 million. Additionally, prescription products net revenue decreased by 60% compared to the second quarter of 2025, when total revenues amounted to approximately $2.9 million.


   

Neonorm: Revenues for the non-prescription Neonorm products were consistent and minimal for the second quarters of 2026 and 2025.

 

     Three Months Ending
June 30,
               
     2026      2025      $ change      % change  

Financial Highlights

           

(in thousands, except per share amounts)

           

License and grant revenue, net

     43        43        0        0

Product revenue, net

     1,182        2,936        (1,754      -60
  

 

 

    

 

 

    

 

 

    

 

 

 

Total revenue , net

   $ 1,225      $ 2,979        (1,754      -59

Loss from operations

   $ (7,597    $ (8,007      410        -5

Net loss attributable to common stockholders

   $ (12,690    $ (10,407      (2,283      22

Net loss per share, basic and diluted

   $ (15.68    $ (358.94      343        -96

 

   

Cost of Product Revenue: The total cost of product revenue increased by $0.5 million, from $0.5 million for the quarter ended June 30, 2025 compared to about $1.0 million for the quarter ended June 30, 2026. The increase in cost was due to sales of inventory to Future Pak in the second quarter of 2026 under the licensing and supply agreement.

 

   

Research and Development: The R&D expense increased by approximately $0.1 million, from $3.2 million for the quarter ended June 30, 2025 compared to $3.3 million for the quarter ended June 30, 2026, primarily due to progress of the development of crofelemer into a powder formulation, a process called lyophilization. This formulation is the new product formulation utilized in the rare disease intestinal failure clinical trials and anticipated for regulatory approval and commercialization.

 

   

Sales and Marketing: The Sales and Marketing expense decreased by approximately $2.5 million, from $2.5 million for the quarter ended June 30, 2025 to approximately $5,000 for the quarter ended June 30, 2026. The decrease was due to the dissolution of the Jaguar/Napo Sales and Marketing Group as of January 12, 2026 following the licensing of Mytesi and Canalevia-CA1 to Future Pak.

 

   

General and Administrative: The G&A expense decreased by approximately $0.3 million, from $4.4 million in the quarter ended June 30, 2025 to $4.7 million in the quarter ended June 30, 2026, largely due to an overall decrease in legal and compliance fees, public company expenses, stock-based compensation and travel expenses.

 

   

Loss from Operations: The loss from operations decreased $0.4 million, going from a loss of $8.0 million in the quarter ended June 30, 2025, to a loss of $7.6 million in the quarter ended June 30, 2026. This change was primarily due to a $1.7 million decrease in product net revenue, which was offset by a reduction in operating expenses of approximately $2.1 million, attributed to the Future Pak licensing agreement.

 

   

Net Loss: Net loss attributable to common shareholders increased by approximately $2.3 million, from a loss of $10.4 million in the quarter ended June 30, 2025 to a loss of $12.7 million in the quarter ended June 30, 2026. In addition to the loss from operations:

 

   

Interest expense increased by $176,000, from $15,000 of interest income for the quarter ended June 30, 2025 to $161,000 in the quarter ended June 30, 2026, due to interest expenses accrued on notes.

 

   

The fair value of financial and hybrid instrument designation at Fair Value Option (“FVO”) increased by about $0.9 million, from a loss of $1.1 million in the quarter ended June 30, 2025 to a loss of $1.9 million in the quarter ended June 30, 2026, primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.

 

   

Loss on extinguishment of debt increased by $1.7 million, from a loss of $1.8 million in the quarter ended June 30, 2025 to a loss of $3.5 million during the three months ended June 30, 2026 due to significant modifications that qualified for extinguishment accounting, with none recorded in the same period in 2025.


   

Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the second quarters of 2026 and 2025 were a net loss of approximately $8.4 million and $7.9 million, respectively.

 

     Three Months Ending
June 30,
    

 

    

 

 
(in thousands)    2026      2025      $ change      % change  
     (unaudited)                

Net loss attributable to common stockholders

   $ (12,690    $ (10,407      2,283        18

Adjustments:

           

Interest income (expense)

     161        (15      (176      109

Property and equipment depreciation

     10        16        6        -57

Amortization of intangible assets

     463        427        (36      8

Share-based compensation expense

     171        279        108        -63

Loss on extinguishment of debt

     3,504        1,822        (1,682      48
  

 

 

    

 

 

    

 

 

    

 

 

 

Non-GAAP EBITDA

     (8,381      (7,878      503        6

Gain on extinguishment of debt

           —      
  

 

 

    

 

 

    

 

 

    

 

 

 

Non-GAAP Recurring EBITDA

   $ (8,381    $ (7,878      503        6

Note Regarding Use of Non-GAAP Measures

The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.

The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar’s performance and provide useful information to investors regarding the Company’s results of operations and financial condition.

About Crofelemer

Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, 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”) develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal (“GI”) disease states. Jaguar family companies Napo Pharmaceuticals, Inc. 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. 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

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.

About Gelclair®

INDICATIONS

GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

IMPORTANT SAFETY INFORMATION

 

   

Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.

 

   

No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.

 

   

If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.

 

   

If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.

Visit www.fda.gov/safety/medwatch or call 1-855-273-0468.

Please see full Prescribing Information at:

https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf

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 clinical package for the NDA (New Drug Application) for crofelemer for MVID will be ready by end of 2026, Jaguar’s expectation that submission of the NDA for crofelemer for MVID will take place in Q2 2027, Jaguar’s expectation that it will hold an investor webcast on August 19, 2026, and Jaguar’s expectation that its powder formulation of crofelemer utilized in the rare disease IF clinical trials will receive regulatory approval and may be approved for commercialization. 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

Filing Exhibits & Attachments

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