Jaguar Health, Inc.
For the period ended Mar 31, 2026. Filed May 20, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 20, 2026
JAGX$0.40-0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-282950
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-20.
0001193125-26-232560
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 183 previous paragraphs and 171 current paragraphs.
55 unchanged; 49 reworded; 64 added; 72 removed; 7 previous and 3 current paragraphs rearranged.
Tables are not compared: 13 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (64)
Current report
Forward Looking Statements
Current report
This Quarterly Report on Form 10-Q (this“Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the“Exchange Act”), adopted pursuant to the Private Securities Litigation Reform Act of 1995. Statements that are not purely historical may be forward-looking. For example, statements in this Quarterly Report regarding our plans, strategy and focus areas are forward-looking statements.
Current report
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 Quarterly Report are only predictions. We have based these forward‑looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. For a discussion of these and other factors that could cause actual results to differ from those contemplated in the forward-looking statements, please see the discussion under“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report, our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our publicly available filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only as of the date of this Quarterly Report. Because actual events or results may differ materially from those discussed in or implied by forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statement. We do not undertake responsibility to update or revise any of these factors or to announce publicly any revision to forward-looking statements, whether as a result of new information, future events or otherwise.
Current report
Jaguar Health, Inc. (“Jaguar”), in conjunction with Jaguar family company Napo Pharmaceuticals, Inc. (“Napo”), develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal (“GI”) disease states. Jaguar family companies Napo and Napo Therapeutics, S.p.A., an Italian corporation Jaguar established in Milan, Italy in 2021, are focused on expanding global crofelemer access and are developing new therapies for orphan and rare GI conditions. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp., is focused on developing novel prescription medicines derived from plants for mental health indications. Jaguar Animal Health is a tradename the Company uses in the animal health space. In the animal health field, the Company focuses on developing and commercializing non-prescription GI products for companion and production animals.
Current report
Napo’s crofelemer 125 mg delayed-release tablets (Mytesi) is an FDA-approved prescription drug for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. In January 2026, following Napo’s entry into a US licensing agreement with an affiliate of privately held Future Pak, LLC (“Future Pak”), Future Pak became the exclusive marketer for Mytesi as well as the tablet formulation for animal health, Canalevia-CA1, which is Jaguar’s crofelemer prescription drug for the treatment of chemotherapy-induced diarrhea in dogs. Jaguar was provided with $16.0 million of non-dilutive capital in January 2026 upon closing of the agreement with Future Pak, with an additional $2.0 million due to Jaguar upon completion of post-closing conditions. Per the terms of the agreement, Jaguar also has the opportunity to receive up to $20 million in milestone payments and other future payments. Jaguar will continue to manufacture crofelemer for Mytesi and Canalevia-CA1 for Future Pak. Mytesi and Canalevia-CA1 are both delayed-release tablet formulations of crofelemer.
Current report
In May 2025, Napo conducted a Type C Meeting with the Division of Gastroenterology at the FDA to discuss the responder analysis results of crofelemer in the cohort of breast cancer patients receiving targeted therapies with or without cytotoxic chemotherapy for prophylaxis of diarrhea from the company’s pivotal OnTarget Phase 3 clinical trial. OnTarget was a 24-week (two 12-week stages), randomized, multicenter, placebo-controlled, double-blind global study to evaluate the safety and efficacy of crofelemer in diarrhea prophylaxis in adult solid tumor patients receiving targeted therapies with or without standard chemotherapy. As previously announced, the top line results from the OnTarget study showed that the trial did not meet its primary endpoint for the prespecified analysis of all tumor types and all targeted therapies. As previously announced, in the prespecified subgroup of patients with breast cancer, crofelemer showed statistically significant improvement in the monthly responder analysis. Breast cancer patients represent one of the largest group of adult patients with solid tumors with patients often remaining on targeted therapy over prolonged periods in both adjuvant and metastatic settings.
Current report
The results in the cohort of patients with breast cancer are based on responder analysis, as was also the primary endpoint in the pivotal Phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication, under the brand name Mytesi, for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Patients with breast cancer accounted for 183 of the 287 participants in the OnTarget clinical trial, and the results of responder analysis for patients with breast cancer were the subject of a poster presentation at the Multinational Association of Supportive Care in Cancer (MASCC) in Seattle in June 2025. A greater proportion of patients with breast cancer randomized to the crofelemer arm were monthly responders for the entire 3-month period of the OnTarget study. This research underscores the potential of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) in adult patients with breast cancer receiving targeted therapies with or without chemotherapy.
Current report
As previously announced, it has been reported that patients with cancer-related diarrhea (“CRD”) were 40% more likely to discontinue chemotherapy or targeted therapy than patients without CRD. The persistence of index cancer therapy and the time to switch were also lower for patients with CRD. Strategies to control CRD and continue cancer therapy are urgently needed. Furthermore, it has been reported that patients with CRD used significantly more resources, including outpatient services, emergency room visits, and hospitalizations. Effective prevention of CRD provides an untapped market opportunity to reduce the overall cost of cancer care. Findings from studies have indicated that patients with CRD had nearly 2.9 times higher all-cause total cost of care than patients without CRD after adjusting for covariates. Thus, prophylaxis of CRD is expected to result in a significant reduction in cancer treatment costs.
Current report
Napo is developing a novel, highly concentrated lyophilized crofelemer powder for oral solution for its prioritized focus on intestinal failure (IF) for the treatment of the ultrarare pediatric disorder, microvillus inclusion disease (MVID), and short bowel syndrome with intestinal failure (SBS-IF). Crofelemer oral powder for solution formulation is a paradigm-shifting and first-in-class drug for the development of novel therapies for these serious unmet medical conditions. This lyophilized oral powder for solution is in advanced clinical development with near-term New Drug Application (NDA) opportunity for MVID and rapid time to market for this potentially breakthrough drug. The lyophilized crofelemer powder for solution has a unique IP position with a long period of exclusivity due to the botanical origin of the drug.
Current report
Intestinal failure (IF) 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 IF 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.
Current report
MVID is an ultrarare, fatal pediatric disorder with around 200 patients in the US and EU combined. There are currently no approved therapies and only lifelong PS, making it one of the most serious unmet medical needs in pediatric patients due to the lethal natural history of the disease. Crofelemer's unique physiological mechanism of modulating intestinal chloride ion secretion results in normalizing electrolyte and fluid balance in the gastrointestinal (GI) tract which reduces the need for electrolyte and fluid requirements through PS. Since MVID patients lack a brush border membrane, this physiological MOA addresses the pathophysiology of MVID, and represents a paradigm-shifting therapy for reduction of PS, which would potentially reduce TPN- and MVID-related comorbidities and improve clinical outcomes.
Current report
SBS-IF affects an estimated 12,000 patients in the US. SBS-IF patients without colon-in-continuity have poor prognosis with significant comorbidities associated with life-sustaining PS and disease pathology. Despite availability of GLP-2 therapies, which require intestinal adaptation of 2-3 years following abdominal surgery in a subset of SBS-IF patients, PS remains the life-sustaining standard of care for these patients. Novel crofelemer powder for oral solution is a first-in-class paradigm-shifting therapy which does not require intestinal adaptation and can be initiated within 6-12 months after surgery upon stabilization of PS. Since it is not a growth hormone, it can be used in SBS-IF patients who have had abdominal surgery due to cancer, mesenteric etiologies, and inflammatory bowel conditions such as Crohn’s disease and colitis. Furthermore, crofelemer, due to its unique physiological MOA of modulating intestinal chloride ion secretion for maintaining electrolyte and fluid balance, can be used in combination with GLP-2 analogs as well as in patients who are either intolerant or for whom GLP-2 is contraindicated.
Current report
Crofelemer was granted Orphan Drug Designation (“ODD”) by the FDA in February 2023 for MVID, an ultra-rare congenital diarrheal disorder (“CDD”), and granted ODD for MVID by the European Medicines Agency (“EMA”) in October 2022. Crofelemer was granted ODD for short bowel syndrome (“SBS”) by the EMA in December 2021 and by the FDA in August 2017. In August 2023, the FDA activated Napo’s Investigational New Drug (“IND”) application for a new crofelemer powder for oral solution formulation for the treatment of MVID.
Current report
Napo is currently supporting multiple proof-of-concept (POC) investigator-initiated trials (IIT), and also conducting two pivotal clinical trials, of crofelemer powder for oral solution for MVID and SBS-IF in the US, European Union (EU), and/or Middle East. The Company’s trial to evaluate the safety and efficacy of crofelemer powder for oral solution in pediatric MVID patients is ongoing at multiple sites. Napo Therapeutics is conducting a Phase 2 study in adult SBS-IF patients at multiple clinical sites in Italy and Germany. An open label IIT is ongoing in pediatric IF patients with MVID and/or SBS in Abu Dhabi in the United Arab Emirates. Groundbreaking results from pediatric IF patients with MVID and SBS-IF were presented at North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN 2025) in Chicago. The study showed that the liquid formulation of crofelemer powder resulted in a reduction of parenteral support (PS) of up to 37% in a pediatric MVID patient who has remained on crofelemer therapy for >1 year. PS reductions of up to 15.6% were observed in two pediatric SBS-IF patients who have also remained on crofelemer oral liquid treatment for >1 year.
Current report
Napo completed its requisite preclinical and formulation activities to support the IND application for NP-300, its second-generation, plant-based oral prescription drug product, for clinical development for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral and parasitic infections including Vibrio cholerae, the bacterium that causes cholera. Following the completion of the Phase 1 trial, the Company will be positioned to initiate the next stage of our clinical development program for cholera-related diarrhea when our development team has the requisite resources and bandwidth to initiate the additional required trials.
Current report
Cholera produces a devastating loss of electrolytes and fluid in patients, and without appropriate reduction in loss of fluid and electrolytes, patients experience significant hospitalization and mortality. NP-300 provides the opportunity to treat cholera patients in combination with oral rehydration salts (“ORS”) and the recommended guidelines from the World Health Organization (“WHO”) for the use of appropriate antibiotics to reduce the burden of the pathogen. Appropriate preclinical toxicity studies and formulation development activities are ongoing to support the conduct of clinical studies with NP-300.
Current report
Napo received partial financial support for preclinical services from the National Institute of Allergy and Infectious Diseases (“NIAID”) of the National Institutes of Health, and Napo is grateful for their support of NP-300’s development.
Current report
Cholera is an acute diarrheal illness caused by intestine infection with the bacterium Vibrio cholerae. According to the Centers for Disease Control and Prevention of the US Department of Health & Human Services, an estimated 1.3 to 4 million people around the world get cholera each year, and 21,000 to 143,000 people die from it. The infection is often mild or without symptoms but can sometimes be severe. Approximately one in ten infected persons will have severe disease characterized by profuse, watery diarrhea, vomiting, and leg cramps. In these people, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours. Cholera is now endemic in many countries outside the US. From January 1, 2024 to July 28, 2024, a cumulative total of 307,433 cholera cases and 2,326 deaths were reported from 26 countries across five World Health Organization (WHO) regions. WHO classified the global resurgence of cholera as a grade 3 emergency in January 2023, the highest internal level for emergencies in WHO. Based on the number of outbreaks and their geographic expansion, alongside the shortage of vaccines and other resources, WHO continues to assess the risk at the global level as very high and the event remains classified as a grade 3 emergency.
Current report
We expect that NP-300 could be significantly less expensive and would support development efforts to receive a tropical disease priority review voucher (“TDPRV”) from the FDA for an indication of the symptomatic treatment of diarrhea from acute infections such as cholera. The FDA grants priority review vouchers as an incentive to develop treatments for neglected diseases and rare pediatric diseases. Priority review vouchers are transferable and, in past transactions by other companies, have sold for prices ranging from $60 million to $350 million. The NP-300 program is paired with funding from a promissory note related to the potential future sale of a possible TDPRV.
Current report
Napo has actively ensured that its intellectual property (“IP”) filings in support of the development of crofelemer for various proposed indications are protected appropriately. The IP portfolio for crofelemer includes the relief and treatment of HIV-associated diarrhea and CID as well as planned indications for inflammatory diarrhea, IBS-D, CDD, and SBS, with all indications, Napo prioritizes IP protection. Napo currently holds approximately 195 patents, the majority of which do not expire until 2027-2031.
Current report
Napo and Napo Therapeutics remain focused on the development of crofelemer powder for solution for the rare disease indications of MVID and SBS-IF. Our management team has significant experience in gastrointestinal product development. We have assembled an impressive group of scientific advisory board (“SAB”) members who work closely with the Chair of Jaguar’s Scientific Advisory Board, Dr. Pravin Chaturvedi, who also serves as the Chief Scientific Officer (“CSO”) of Jaguar.
Current report
Revenues from the sale of Mytesi and Canalevia, which are sold exclusively to Woodward pursuant to the Supply Agreement entered into on January 12, 2026. Under this arrangement, Napo manufactures or has the Mytesi Product manufactured and supplies it to the Licensee for commercialization in the U.S.
Current report
Research and Development
Current report
We capitalize certain tangible research and development materials, such as API and intermediate lyophilized products, that have a probable alternative future use. We reclassify and expense these materials as R&D expense when they are consumed in research activities or become specifically dedicated to a clinical trial. The determination of when materials are "specifically dedicated" to a clinical trial is a critical accounting estimate because it requires significant management judgment. We evaluate dedication based on several factors, including the finalization of clinical protocols, trial-specific labeling requirements, and the initiation of trial-specific manufacturing or packaging runs. If management’s judgment regarding the timing or probability of clinical trial commencement were to change, it could result in the immediate expensing of significant capitalized balances. A material delay or change in clinical strategy could result in the recognition of substantial R&D expenses in a single period, which could materially impact our reported results of operations.
Current report
Sales and Marketing
Current report
On January 12, 2026, Napo and the Company entered into a license agreement with Woodward Specialty LLC (“Woodward”), an affiliate of Future Pak, LLC (“Future Pak”), and Future Pak, pursuant to which, Napo granted to Woodward an exclusive, nontransferable, sublicensable, royalty-free right and license (subject to certain exceptions as set forth in the License Agreement) under the Napo Mytesi Patents (as defined in the License Agreement) to sell, offer for sale, have sold, make, have made, promote, distribute and otherwise commercialize the Mytesi Product and the Canalevia Product. Thus, we expect no sales and marketing expenses for these products going forward.
Current report
General and Administrative Expense
Current report
The decrease in gross product revenue of $1.9 million for three months ended March 31, 2026 compared to the same period in 2025, was primarily due to the decrease in sales volume of Mytesi.
Current report
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates were $64,000 and $735,000 for the three months ended March 31, 2026 and 2025, respectively, a decrease of $671,000 due to lower product utilization within the program coupled with changes in rebate agreements.
Current report
Sales discounts were $24,000 and $260,000 for the three months ended March 31, 2026 and 2025, respectively, a decrease of $236,000 due to changes in sales discount arrangements to various customers.
Current report
The following table presents the components of cost of product revenue for the three months ended March 31, 2026 and 2025, together with the change in such components in dollars and as a percentage:
Current report
The increase in cost of product revenue of $643,000 for the three months ended March 31, 2026 compared to 2025 was primarily due to:
Current report
Material cost increased by $772,000 from $189,000 for the three months ended March 31, 2025 to $961,000 in the same period in 2026, due to the sale of remaining Mytesi and Canalevia inventory on hand under the licensing and supply agreement with Woodward (affiliate of Future Pak).
Current report
Direct labor decreased by $172,000 from $228,000 for the three months ended March 31, 2025 to $56,000 in the same period in 2026, due to the decreased time spent by employees manufacturing Mytesi because of the production schedule in the first quarter.
Current report
Research and Development
Current report
Clinical and contract manufacturing expenses increased by $838,000 from $1.3 million for the three months ended March 31, 2025 to $2.1 million in the same period in 2026. The increase was primarily attributable to the progression of crofelemer lyophilization into the development phase, which resulted in higher clinical trial–related costs and increased external contract manufacturing services related to lyophilization activities.
Current report
Personnel and related benefits decreased by $222,000 from $1.5 million for the three months ended March 31, 2025 to $1.3 million in the same period in 2026, due to a reduction in force (RIF) within the Clinical and QA groups, which resulted in lower headcount for clinical trial, research, and quality assurance functions during the period.
Current report
Stock-based compensation expense decreased by $60,000 from $117,000 for the three months ended March 31, 2025 to $57,000 in the same period in 2026, due to higher RSU cancellations and decline in fair value of newly granted options, despite the increase in higher options and RSUs granted during the current year.
Current report
Other R&D expenses decreased by $44,000 from $106,000 million for the three months ended March 31, 2025 to $62,000 million in the same period in 2026, due to the RIF within the Clinical and QA groups and the conclusion of the Phase 3 ON Target clinical trial, both of which reduced travel requirements for research and clinical purposes.
Current report
The following table presents the components of R&D expense per project for the three months ended March 31, 2026 and 2025, together with the change in such components in dollars and as a percentage:
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Removed paragraphs (72)
Previous report
Jaguar Health, Inc. (“Jaguar” or the “Company”) is a commercial-stage pharmaceuticals company focused on developing and commercializing novel, plant-based, sustainably derived prescription FDA-approved oral crofelemer delayed-release tablet formulation for the symptomatic relief of diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy; (Mytesi) and for chemotherapy-induced diarrhea (CID) in dogs (Canalevia-CA1). Crofelemer ameliorates the gastrointestinal (“GI”) symptoms and distress, including chronic, debilitating diarrhea and is developed and commercialized by Jaguar’s wholly owned subsidiary, Napo Pharmaceuticals, Inc. (“Napo”). Napo is also focused on developing and commercializing a novel oral liquid formulation of crofelemer for other significant unmet supportive care GI needs in complex orphan indications, such as short bowel syndrome (SBS) and microvillus inclusion disease (MVID), using a proprietary and novel oral liquid formulation of crofelemer.,. Napo is also developing crofelemer delayed-release tablets for the prophylaxis of diarrhea in adult solid tumor patients receiving targeted therapies with or without standard chemotherapy, which is the subject of the OnTarget study, a recently conducted pivotal Phase 3 clinical trial. While the initial top line results from the OnTarget study showed that this multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary endpoint for the prespecified analysis of all tumor types, an analysis by the Company of the prespecified subgroup of adult patients with breast cancer from OnTarget indicates that crofelemer achieved statistical significance in this subgroup. Patients with breast cancer accounted for 183 of the 287 participants in this trial in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. The OnTarget results in breast cancer patients were the subject of a poster presentation conducted December 11, 2024 at the San Antonio Breast Cancer Symposium (“SABCS”). Overall, crofelemer was significantly more effective than placebo in providing sustained response for the prophylaxis of cancer therapy-related diarrhea (CTD) in breast cancer patients in the OnTarget study. This research underscores the potential of crofelemer for prophylaxis of CTD for adult patients with breast cancer.
Previous report
A late-breaker abstract by Napo to the Multinational Association of Supportive Care in Cancer (“MASCC”) on additional significant results over the 3-month treatment period in adult breast cancer patients from the OnTarget study were the subject of an oral rapid e-poster at MASCC’s June 26-28, 2025 Annual Meeting.
Previous report
Jaguar is also the majority stockholder of Napo Therapeutics S.p.A. (“Napo Therapeutics”), an Italian corporation established by Jaguar in Milan, Italy in 2021, focusing on expanding crofelemer development and commercialization in Europe. Napo Therapeutics’ core mission is to provide access to crofelemer in Europe to address significant orphan disease indications, including, initially, short bowel syndrome with intestinal failure (“SBS-IF”) and microvillus inclusion disease (“MVID”), an ultrarare pediatric congenital diarrheal disorder (“CDD”).
Previous report
Magdalena Biosciences, Inc. (“Magdalena”), a joint venture formed by Jaguar and Filament Health Corp. (“Filament”) that emerged from Jaguar’s Entheogen Therapeutics Initiative (“ETI”), is focused on identifying the next generation of plant-based first-in-class agents for treatment of mental health and central nervous system (“CNS”) conditions.
Previous report
Napo’s marketed drug Mytesi (crofelemer 125 mg delayed-release tablets) which is a first-in-class oral botanical drug product approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. To date, this is the only oral plant-based botanical prescription medicine approved under the FDA’s Botanical Guidance. Jaguar’s Canalevia-CA1 (crofelemer delayed-release tablets) drug is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (“CID”) in dogs.
Previous report
Jaguar, through Napo and Napo Therapeutics, is currently supporting two independent proof-of-concept (“POC”) investigator-initiated trials (“IIT”), and conducting two placebo-controlled Phase 2 studies, of crofelemer in patients with intestinal failure due to the orphan indications of adult short bowel syndrome (“SBS”) and pediatric microvillus inclusion disease (“MVID”) in the United States, European Union, and/or Middle East/North Africa regions.
Previous report
As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of an ongoing IIT of a novel crofelemer powder formulation for oral solution in Abu Dhabi in the United Arab Emirates show that crofelemer reduced the required total parenteral nutrition (“TPN”) and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, these data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output – an indicator of potentially improved nutrient enteral absorption.
Previous report
As announced in June 2025, initial proof-of-concept results from this ongoing exploratory, single-arm open label non-randomized IIT in Abu Dhabi also show that crofelemer reduced the required TPN and supplementary intravenous fluids in a third pediatric intestinal failure patient – a patient with SBS-IF. The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period intended to last 30 days, per the study protocol, but were promptly placed back on daily crofelemer treatment because their symptoms worsened following cessation of crofelemer therapy and the patients responded well following reinitiation of crofelemer treatment.
Previous report
The Company’s strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar's intestinal failure products – with the goal of generating non-dilutive funding for Jaguar.
Previous report
Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer’s paradigm-shifting physiological antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric patients with intestinal failure due to MVID and adult and/or pediatric intestinal failure patients with SBS. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by significant morbidity and mortality due to severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which there are no approved drug treatments, or any potential approaches to reduce TPN.
Previous report
As of June 23, 2025, as announced, enrollment in the Napo-sponsored first-of-its-kind placebo-controlled Phase 2 study to evaluate the safety and efficacy of crofelemer for treatment of MVID in pediatric patients was at approximately 25% and patient screening is continuing. For the Company’s placebo-controlled Phase 2 study to evaluate the safety and efficacy of crofelemer for
Previous report
SBS-IF in adults, enrollment is above 10%, and patient screening is continuing. Additionally, enrollment is continuing in the two ongoing proof-of-concept IITs. These are important milestones in development efforts for crofelemer for the treatment and management of intestinal failure associated with these devastating orphan diseases. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs.
Previous report
The global Phase 2 trial of a novel and proprietary crofelemer powder for oral solution in adults with SBS-IF is taking place under a Clinical Trial Application (“CTA”) approved by European Medicines Agency (EMA). In August 2023, Napo’s Investigational New Drug (“IND”) application was activated by the FDA for the development of the novel and proprietary crofelemer powder for oral solution formulation for treating MVID. The MVID Phase 2 trial for Napo was expanded to be a global clinical trial and has received regulatory clearances from EMA as well as the Ministry of Health from the United Arab Emirates (UAE) for conducting the clinical trial in pediatric MVID patients with intestinal failure. We expect that enrollment will continue in 2025 for the MVID Phase 2 trial and the Phase 2 trial for SBS-IF, with data expected in late 2026 for both trials.
Previous report
The IIT in Abu Dhabi is being conducted by Dr. Miqdady at Sheikh Khalifa Medical City (SKMC), a flagship tertiary hospital in the United Arab Emirates and the largest teaching medical center in Abu Dhabi. Dr. Miqdady, a recognized leader in pediatric gastroenterology, serves as the Chief of Pediatric Gastroenterology, Hepatology and Nutrition at SKMC. He is an American board-certified pediatric GI, hepatology and nutrition professor at Khalifa University in Abu Dhabi, and also serves as a member of Napo's Scientific Advisory Board.
Previous report
Most of the activities of the Company are focused on the development of crofelemer tablets for CTD and commercialization of Mytesi for HIV-related diarrhea. Furthermore, the ongoing clinical development of crofelemer for the prophylaxis and treatment of diarrhea in adult metastatic breast cancer patients receiving targeted cancer therapy, and our prioritized clinical program centered around development of the novel and proprietary crofelemer powder for oral solution for the treatment of intestinal failure due to MVID and SBS. The Company has also launched Gelclair for mitigating oral mucositis in adult cancer patients.
Previous report
In the field of animal health, we are continuing limited activities related to developing and commercializing crofelemer delayed-release tablets (Canalevia-CA1) for dogs. In December 2021, we received conditional approval from the FDA to market Canalevia, under the name Canalevia-CA1 (crofelemer delayed-release tablets), for the treatment of chemotherapy-induced diarrhea (“CID”) in dogs. Canalevia-CA1, the first and only treatment for CID in dogs to receive any type of approval from the FDA, is now available from multiple leading veterinary distributors in the US. 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.
Previous report
Crofelemer is a novel, first-in-class anti-secretory antidiarrheal drug that has a normalizing effect on electrolyte and fluid balance in the gut, and this mechanism of action has the potential to benefit multiple disorders that cause GI distress, including diarrhea and abdominal discomfort. Crofelemer delayed-release tablets have also been evaluated in adult patients with diarrhea-predominant irritable bowel syndrome (“IBS-D”) and chronic idiopathic and functional diarrhea in investigator-initiated human trials.
Previous report
In the EU, it may be possible to obtain approval of Canalevia for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea. While this trial did not meet its stated primary endpoint, the study results are clinically significant when analyzed using an alternate, simplified endpoint, defining treatment success as any dog that had no episodes of diarrhea following the first treatment with either Canalevia or placebo. Using this revised endpoint, the study data shows that dogs treated with Canalevia had significantly better outcomes – with fewer watery stools and significant improvement in fecal scores compared to placebo-treated dogs.
Previous report
Jaguar plans to submit a dossier to the EMA’s CVMP to outline the results of the updated analysis of the Company’s completed study of Canalevia in dogs with general diarrhea. If acceptable to the EMA, the company will then submit a Marketing Authorization Application (“MAA”) for Canalevia for general diarrhea in dogs. If the application is approved, Canalevia will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries.
Previous report
We have been pleased with the marketplace reception of crofelemer for treatment of CID in dogs in the US and believe there is clearly an unmet medical need for a product for the much larger market of treatment of general diarrhea in dogs – both in the US and the EU. We estimate that US veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to identifying a partner to fund and execute development and commercialization of crofelemer for the treatment of general diarrhea in the US and/or globally. Forging a partnership for this purpose is a key focus of our business development efforts in 2025 and has been designated as a key potential catalyst for the Company this year.
Previous report
Revenues from the sale of our human drug Mytesi, which is sold through distributors and wholesalers and specialty pharmacies.
Previous report
We expect sales and marketing expenses to remain flat going forward as we focus on efficiency supporting commercialization efforts and commercial partnerships to pursue potential in-licensing opportunities for commercial-stage products, thereby continuing to build our Oncology portfolio.
Previous report
The following table summarizes the Company’s operations results for the items outlined in the table for the nine months ended September 30, 2025 and 2024, together with the change in such items in dollars and as a percentage.
Previous report
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates accounted for $2.0 million and $1.9 million for the nine months ended September 30, 2025 and 2024, respectively, an increase of $100,000.
Previous report
Sales discounts were $918,000 and $838,000 for the nine months ended September 30, 2025 and 2024, respectively, an increase of $80,000, relative to the increase in sales volume.
Previous report
Our gross product revenues were $11.1 million and $11.0 million for the nine months ended September 30, 2025 and 2024, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Canalevia-CA1, Neonorm Calf and Neonorm Foal.
Previous report
The increase in gross product revenue of $132,000 for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily due to the increase in the volume of sales of Gelclair and Neonorm, added to the price per bottle increase for Mytesi during the period. The Company launched Gelclair in the fourth quarter of 2024. Revenue recognition continued this quarter in line with the timing of product sales and applicable revenue recognition principles.
Previous report
The increase in cost of product revenue of $176,000 for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to higher costs incurred for materials, outsourced contract manufacturing services and other costs, partially offset by changes in distribution fees.
Previous report
The following table presents the components of research and development (“R&D”) expense for the nine months ended September 30, 2025 and 2024, together with the change in such components in dollars and as a percentage:
Previous report
Clinical trial expenses and contract manufacturing costs decreased by $1.0 million from $4.8 million for the nine months ended September 30, 2024, to $3.8 million in the same period in 2025 as the CTD Phase 3 On Target Clinical Trial concluded, reducing the clinical trial-related costs and external contract manufacturing services.
Previous report
Stock-based compensation decreased by $328,000 from $562,000 for the nine months ended September 30, 2024, to $234,000 in the same period in 2025 primarily due to higher option and RSU forfeitures and cancellations during the period.
Previous report
Travel and other expenses increased by $74,000 from $133,000 for the nine months ended September 30, 2024, to $207,000 in the same period in 2025 due to the R&D group's participation in a one-time global event in Rome, Italy, for the MVID investigators conference and contract signing.
Previous report
Other research and development expenses increased by $212,000 from $277,000 in the nine months ended September 30, 2024, to $489,000 in the same period in 2025 primarily due to the expenses incurred on two lots of API used for formulation development.
Previous report
The increase in S&M expense of $2.0 million for the nine months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Previous report
Personnel and related benefits increased by $1.4 million from $2.3 million for the nine months ended September 30, 2024, to $3.8 million in the same period in 2025 primarily due to additional headcount for the Gelclair sales team.
Previous report
Direct marketing fees and expenses increased by $928,000 from $949,000 for the nine months ended September 30, 2024, to $1.9 million in the same period in 2025 due to broader promotional activities associated with the launch of Gelclair campaign.
Previous report
Other sales and marketing expenses decreased by $408,000 from $1.2 million for the nine months ended September 30, 2024, to $825,000 in the same period in 2025 primarily due to the absence of placement fees to recruiters as no additional personnel hiring was required during the period.
Previous report
The increase in G&A expenses of $1.3 million for the nine months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Previous report
Legal services increased by $1.2 million from $1.6 million for the nine months ended September 30, 2024, to $2.8 million in the same period in 2025 due to higher corporate legal expenses which were mostly associated with increased financing and public securities activities.
Previous report
Public company expenses decreased by $222,000 from $1.4 million for the nine months ended September 30, 2024, to $1.1 million in the same period in 2025 due to lower printing costs from Company's transition to new financial regulatory filing and financial compliance service provider.
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Reworded paragraphs (49)
Previous wording
The following discussion and analysis of financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes included in Item 1 of Part I of this Quarterly Report on Form 10‑Q and with our audited consolidated financial statements and the related notes included in our Annual Report on Form 10‑K as of and for the year ended December 31, 2024 which was filed to the SEC on March 31, 2025 and amended on April 15, 2025.
Current wording
The following discussion and analysis of financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes included in Item 1 of Part I of this Quarterly Report and with our audited consolidated financial statements and the related notes included in our Annual Report on Form 10‑K as of and for the year ended December 31, 2025.
Previous wording
On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017, by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo’s representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as the wholly owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the Merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly owned subsidiary of Jaguar focused on human health including the ongoing development of crofelemer and commercialization of Mytesi.
Current wording
Jaguar was founded in San Francisco, California, as a Delaware corporation on June 6, 2013 (“inception”). The Company was a majority-owned subsidiary of Napo until the close of the Company's initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class prescription and non-prescription products for companion animals. On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017, by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo's representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as the wholly owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the Merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly owned subsidiary of Jaguar focused on human health, including the ongoing development of crofelemer and commercialization of Mytesi.
Previous wording
The currently estimated US metastatic breast cancer population potentially also qualifies as an orphan population, in alignment with the Company’s core focus on orphan diseases. The Company therefore intends to request orphan drug designation from the FDA for the CTD indication in this population. Given crofelemer’s novel and paradigm-shifting physiological mechanism of action, the Company also plans to seek Fast Track designation from the FDA to support potentially expedited regulatory review and potential approval in the US for crofelemer for CTD in metastatic breast cancer patients.
Current wording
In the second half of 2026, based on discussions with the FDA in May 2025, the company plans to submit to the FDA the final clinical study report (CSR) for the OnTarget trial together with additional details of the responder analysis in the cohort of breast cancer patients, along with a patient survey evaluating clinically meaningful reductions in the frequency of weekly loose/watery stools for patients metastatic cancer patients receiving targeted therapies with or without standard chemotherapy. The currently estimated US metastatic breast cancer population potentially also qualifies as an orphan population, in alignment with the Company’s core focus on orphan diseases. The Company therefore intends to request orphan drug designation from the FDA for the CTD indication in this population. Given crofelemer’s novel and paradigm-shifting physiological mechanism of action, the Company also plans to seek Fast Track designation from the FDA to support potentially expedited regulatory review and potential approval in the US for crofelemer for CTD in metastatic breast cancer patients.
Previous wording
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. Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.
Current wording
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, and the US population of SBS-IF patients was estimated at 12,000 patients in 2021 in a well-done epidemiology study. Despite limited treatment options, the global market for SBS was valued at $2 billion in 2024 and is projected to reach $6.4 billion by 2030, according to a report by ResearchAndMarkets.com. MVID is an ultrarare pediatric disease, with an estimated prevalence of a couple of hundred patients globally. Jaguar estimates that the global market size for MVID therapies is in the range of $50 million to $100 million, based on market research with key opinion leaders (KOLs) and payers.
Previous wording
In both the US and European Union, crofelemer has been granted orphan drug designation for the orphan diseases SBS and MVID. Crofelemer has also been granted orphan drug designation for treatment of diarrhea in cholera in the US, where cholera is an orphan disease. Orphan drug designation in the US qualifies the sponsor of a drug for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. Additionally, orphan drug designation in the US provides a seven-year period of marketing exclusivity to the first sponsor who obtains marketing approval for the designated orphan drug. Sponsors who obtain orphan drug designation in the EU for their drug can benefit from Scientific Advice from the EMA for clinical trials for the orphan indication and receive market exclusivity for a period of ten years once the medicine is approved for commercialization.
Current wording
The Orphan Drug Act (“ODA”) in the US grants special status to a small molecule drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as ODD (or sometimes "orphan status"). ODD qualifies the drug's sponsor for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. Additionally, the ODA provides a seven-year period of marketing exclusivity to the first sponsor who obtains marketing approval for a designated orphan drug. In the EU, receipt of ODD supports some specific regulatory pathways, and sponsors who obtain ODD for their drug can benefit from Scientific Advice from the EMA for clinical trials for the orphan indication and receive market exclusivity for a period of ten years once the medicine is approved for commercialization.
Previous wording
In accordance with the guidelines of specific European Union countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for these debilitating conditions in late 2026 while the Company pursues approval of crofelemer for MVID from the EMA and the FDA. Participation in early access programs, which do not exist in the US, provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs. Additionally, the Company expects that if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow pathways for regulatory approval in the US and other regions and qualify crofelemer for participation in PRIME, a European Medicines Agency (EMA) program providing enhanced interaction and early dialogue with drug developers of novel medicines targeting unmet medical needs, and potentially in the FDA’s Breakthrough Therapies program.
Current wording
Napo is also supporting an IIT in the US to evaluate crofelemer powder for oral solution for treatment of adult SBS-IF patients. The Company plans to pursue approval of crofelemer powder for oral solution for MVID in the US following the completion of the pivotal pediatric MVID trial. In accordance with the guidelines of specific EU countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for these debilitating IF conditions. Participation in early access programs, which do not exist in the US, provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs. Additionally, the Company expects that if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow expedited pathways for regulatory approval in the US. Napo Therapeutics plans to pursue the opportunity for crofelemer powder for oral solution for PRIME designation, a European Medicines Agency (EMA) program providing enhanced interaction and early dialogue with drug developers of novel medicines targeting unmet medical needs. In the US, Napo plans to pursue Breakthrough Therapy Designation (BTD) from the FDA. If a drug is designated as breakthrough therapy, the FDA will expedite the review timeline for the drug.
Previous wording
In addition, a second-generation proprietary anti-secretory antidiarrheal drug (“NP-300”) is in development for the symptomatic relief and treatment of moderate-to-severe diarrhea in adult human subjects, with or without concomitant antimicrobial therapy, from bacterial, viral, and parasitic infections, including Vibrio cholerae, the bacterium that causes cholera. This program is being pursued with the potential targeted incentive from the FDA for a tropical disease priority review voucher.
Current wording
In addition, a second-generation proprietary anti-secretory antidiarrheal drug (“NP-300”) is in development for symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral, and parasitic infections, including Vibrio cholerae, the bacterium that causes cholera. This program is being pursued with the potential targeted incentive of a tropical disease review voucher from the FDA.
Previous wording
As part of our strategy to expand our commercial footprint beyond the FDA approved crofelemer indication for HIV-related supportive care, to include cancer-related supportive care, on April 12, 2024, we entered into an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC (“Venture Life”), an international consumer health company focused on the global self-care market, for Venture Life’s 510(k) cleared oral mucositis prescription product, Gelclair, for the US market. Gelclair is a 510(k) cleared prescription product and can be commercialized without any clinical development costs for Jaguar. We initiated the commercial launch in October 2024 for Gelclair. Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a protective gel with 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. Unlike other products for oral mucositis, it is not a local anesthetic (numbing) agent and does not sting the mouth.
Current wording
In keeping with the Company’s focus on supportive care for patients undergoing cancer treatment, Jaguar in April 2024 signed an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC ("Venture Life"), an international consumer health company focused on the global self-care market, for Venture Life's FDA-approved oral mucositis prescription product, Gelclair, for the US market. In October 2024, Jaguar initiated the commercial launch of Gelclair, the Company’s third commercialized prescription product, in the US.
Previous wording
In January 2023, Jaguar and Filament, with funding from One Small Planet, formed the US-based joint venture Magdalena. Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health and central nervous system (“CNS”) indications. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This venture aligns with Jaguar’s ETI program and Filament’s corporate mission to develop novel, natural prescription medicines from plants. Magdalena will leverage Jaguar’s proprietary medicinal plant library and Filament’s proprietary drug development technology. Magdalena holds an exclusive license to plants and plant extracts in Jaguar’s library, not including any sources of crofelemer or NP-300, for specific indications and is in the process of identifying plant candidates in the library that may prove beneficial for addressing specific mental health and CNS indications. Magdalena is currently approximately 40-percent owned by Jaguar.
Current wording
In January 2023, Jaguar and Filament Health, with funding from One Small Planet, formed the US-based joint venture Magdalena Biosciences (“Magdalena”). Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health indications, including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This venture aligns with Jaguar's Entheogen Therapeutics Initiative (ETI) and Filament’s corporate mission to develop novel, natural prescription medicines from plants. Magdalena is leveraging Jaguar’s proprietary medicinal plant library and Filament’s proprietary drug development technology. Jaguar’s library of 2,300 highly characterized medicinal plants and 3,500 plant extracts, all from firsthand ethnobotanical investigation by Jaguar and members of the ETI Scientific Strategy Team. Magdalena is currently approximately 40-percent owned by Jaguar.
Previous wording
Canalevia-CA1 is a tablet that is given orally and can be prescribed for home treatment of CID. The FDA conditionally approved Canalevia-CA1 under application number 141-552. Conditional approval allows for product commercialization while Jaguar Animal Health continues to collect the substantial evidence of effectiveness required for full approval. We have received a Minor Use in a Major Species (“MUMS”) designation from the FDA for Canalevia-CA1 to treat CID in dogs.
Current wording
In the field of animal health, Jaguar Animal Health is continuing limited activities related to developing first-in-class gastrointestinal products for dogs. In December 2021, the Company received conditional approval from the FDA to market Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. The FDA conditionally approved Canalevia-CA1 under application number 141-552. Conditional approval allows for product commercialization while Jaguar Animal Health continues to collect the substantial evidence of effectiveness required for full approval. We have received a Minor Use in a Major Species (“MUMS”) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS Act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.
Previous wording
Jaguar’s primary objective for Canalevia is to identify a partner with which to collaborate to achieve our three parallel goals for the drug: Obtain approval in the EU for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; maintain continuity of availability in the US of Canalevia for treatment of CID in dogs; and to expand the US indication from CID in dogs to treatment of general diarrhea in dogs. Jaguar has been in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally.
Current wording
As announced, the Company plans to pursue approval from the EMA’s Committee for Veterinary Medicinal Products (“CVMP”) for Canalevia in the European Union for treatment of general diarrhea in dogs. Jaguar’s primary objective for Canalevia is to identify a partner with which to collaborate to achieve our three parallel goals for the drug: Obtain approval in the EU for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; maintain continuity of availability in the US of Canalevia for treatment of CID in dogs; and to expand the US indication from CID in dogs to treatment of general diarrhea in dogs.
Previous wording
We believe Jaguar is poised to realize a number of near-term catalysts and value-adding benefits from an expanded pipeline of potential blockbuster human follow-on indications of crofelemer and NP-300, a second-generation anti-secretory agent-upon which to build global partnerships. Jaguar, through Napo, holds global unencumbered rights for crofelemer powder for oral solution, Mytesi, and Canalevia-CA1. Additionally, several drug product opportunities in Jaguar’s crofelemer pipeline are backed by Phase 2 and POC evidence from human clinical trials.
Current wording
We believe Jaguar is poised to realize the opportunities for the commercialization of crofelemer powder for oral solution for our IF programs from MVID and SBS-IF. Jaguar, through Napo, holds global unencumbered rights for crofelemer.
Previous wording
On a consolidated basis, we have not yet generated enough revenue to date to achieve break-even or positive cash flows, and we expect to continue to incur significant research and development and other expenses. Our net loss was $30.8 million and $29.0 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had a total stockholders' equity of $4.4 million, an accumulated deficit of $376.9 million, and cash of $3.5 million. We expect to continue to incur losses, and experience increased expenditures for the foreseeable future as we expand our product development activities, seek necessary approvals for our product candidates, conduct species-specific formulation studies for our non-prescription products, establish API manufacturing capabilities and begin additional commercialization activities. Payments of cash compensation to directors under the Director Compensation Program for the nine months ended September 30, 2025 and 2024, amounted to $322,000 and $321,000, respectively.
Current wording
On a consolidated basis, we have not yet generated enough revenue to date to achieve break-even or positive cash flows, and we expect to continue to incur significant research and development and other expenses. Our net income (losses) were $8.7 million net income and $10.6 million net losses for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had a total stockholders' deficit of $15.8 million, an accumulated deficit of $391.1 million, an accumulated other comprehensive loss of $1.2 million and cash of $7.3 million. We expect to continue to incur losses, and experience increased expenditures for the foreseeable future as we expand our product development activities, seek necessary approvals for our product candidates, conduct species-specific formulation studies for our non-prescription products, establish API manufacturing capabilities and begin additional commercialization activities. Payments of cash compensation to directors under the Director Compensation Program for the three months ended March 31, 2026, amounted to $109,000.
Previous wording
Our product and license revenue consists of the following:
Current wording
Our product and collaboration revenue consists of the following:
Previous wording
Revenues from the sale of our animal products branded as Canalevia-CA1, Neonorm Calf and Neonorm Foal. Our Canalevia-CA1, Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers.
Current wording
Revenues from the sale of our animal products branded as Neonorm Calf and Neonorm Foal. Our Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers.
Previous wording
Revenues from the license agreement made with Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S., ("Gen") ("Licensee") from which all finished Mytesi are sold in the licensed territory.
Current wording
Revenues from the license agreement made with Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S., ("Gen" or "Licensee") from which all finished Mytesi are sold in the licensed territory.
Previous wording
See “Results of Operations” below for a more detailed discussion on revenues.
Current wording
See “Results of Operations” below for more detailed discussion on revenues.
Previous wording
Research and development expenses consist primarily of clinical trial expenses and contract manufacturing costs, personnel and related benefits, stock-based compensation, employee travel, and reforestation expenses. Clinical and contract manufacturing expenses consist primarily of costs for executing clinical study protocols for safety and efficacy together with evaluating the stability, and manufacturing costs for crofelemer delayed-release tablets as well as crofelemer drug substance from Glenmark an outsourced, FDA-approved crofelemer API provider in India. It also includes expenses with a third-party provider for transferring the Mytesi manufacturing process and the related feasibility and validation activities at a contract manufacturing facility in the US.
Current wording
Research and development ("R&D") expenses consist primarily of clinical trial expenses and contract manufacturing costs, personnel and related benefits, stock-based compensation, employee travel, and reforestation expenses. Clinical and contract manufacturing expenses consist primarily of costs for executing clinical study protocols for safety and efficacy together with evaluating the stability, and manufacturing costs for crofelemer delayed-release tablets as well as crofelemer drug substance from Alivus an outsourced, FDA-approved crofelemer API provider in India. It also includes expenses with a third-party provider for transferring the Mytesi manufacturing process and the related feasibility and validation activities at a contract manufacturing facility in the US.
Previous wording
As of September 30, 2025, the Company has incurred approximately $3.8 million on its primary R&D projects. The timing and amount of our research and development expenses will depend largely upon the outcomes of current and future trials for our prescription drug product crofelemer, as well as the related regulatory requirements, the outcomes of current and future species-specific formulation studies for our non-prescription products, manufacturing costs and any costs associated with the advancement of our line extension programs. We cannot determine with certainty the duration and completion costs of the current or future development activities. The total project costs remain uncertain due to regulatory and clinical trial complexities. Management continues to monitor timelines closely to address any risks that could impact timely project completion and future operations.
Current wording
As of March 31, 2026, the Company has incurred approximately $25.0 million on its primary R&D projects. The timing and amount of our research and development expenses will depend largely upon the outcomes of current and future trials for our prescription drug product candidates, as well as the related regulatory requirements, the outcomes of current and future species-specific formulation studies for our non-prescription products, manufacturing costs and any costs associated with the advancement of our line extension programs. We cannot determine with certainty the duration and completion costs of the current or future development activities. The total project costs remain uncertain due to regulatory and clinical trial complexities. Management continues to monitor timelines closely to address any risks that could impact timely project completion and future operations.
Previous wording
Sales and marketing expenses consist of personnel and related benefits, stock-based compensation, direct sales and marketing, distribution, employee travel, and management consulting expenses. We currently incur sales and marketing expenses to promote Mytesi and Gelclair. We do not have significant marketing or promotional expenses related to Canalevia and Neonorm Calf or Neonorm Foal for the nine months ended September 30, 2025 and 2024.
Current wording
Sales and marketing expenses consist of personnel and related benefits, stock-based compensation, direct sales and marketing, employee travel, and management consulting expenses. We currently incur sales and marketing expenses to promote Mytesi and Gelclair. We do not have significant marketing or promotional expenses related to Canalevia-CA1 and Neonorm Calf or Neonorm Foal for the three months ended March 31, 2026 and 2025.
Previous wording
General and administrative expenses consist of personnel and related benefits expenses, stock-based compensation expenses, employee travel expenses, legal and accounting fees, rent and facilities expenses, and management consulting expenses.
Current wording
General and administrative expenses consist of personnel and related benefit expense, stock‑based compensation expense, employee travel expense, legal and accounting fees, rent and facilities expense, and management consulting expense.
Previous wording
In the near term, we expect general and administrative expenses to remain flat as we focus on our pipeline development and market access expansion. This will include efforts to grow the business.
Current wording
In the near term, we expect general and administrative expense to decrease as we focus on our pipeline development and market access expansion on our Intestinal Failure (IF) programs.
Previous wording
Changes in fair value of financial instruments and hybrid instruments designated at FVO consists of gain or loss recognized related to fair values changes of our instruments designated at FVO.
Current wording
Change in fair value of freestanding and hybrid financial instruments designated at Fair Value Option consists of gain or loss recognized related to fair values changes of our instruments designated at FVO.
Previous wording
Gain (Loss) on Extinguishment of Debt
Current wording
Gain (Loss) on Debt Extinguishment
Previous wording
Preparing condensed consolidated financial statements in conformity with US GAAP requires using estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures in the consolidated financial statements. Critical accounting policies are those accounting policies that may be material due to the levels of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change and that have a material impact on financial condition or operating performance. While we base our estimates and judgments on our experience and various other factors that we believe to be reasonable, actual results may differ from these estimates under different assumptions or conditions. Note 2 of the unaudited condensed consolidated financial statements describes our significant accounting policies. Our critical accounting policies and estimates were described in Part II, Item 7, Critical Accounting Policies and Estimates, in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
The preparation of financial statements in conformity with US generally accepted accounting principles (“US GAAP”) requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosures in the financial statements. Critical accounting policies are those accounting policies that may be material due to the levels of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change, and that have a material impact on financial condition or operating performance. While we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances, actual results may differ from these estimates under different assumptions or conditions. We believe the following critical accounting policies used in the preparation of our financial statements require significant judgments and estimates. For additional information relating to these and other accounting policies, see Note 2 to the consolidated financial statements, appearing elsewhere in this report.
Previous wording
For three and nine months ended September 30, 2025, the only material impacts of IRA are a significant reduction in the Company’s Medicare Part D rebates payable to CMS and a reduction in patients’ out-of-pocket copays for their Mytesi prescriptions. Management continues to assess the evolving implications of the IRA on pricing, reimbursement, and research incentives.
Current wording
For the three months ended March 31, 2026, the only material impacts of IRA are a significant reduction in the Company’s Medicare Part D rebates payable to CMS and a reduction in patients’ out-of-pocket copays for their Mytesi prescriptions. Management continues to assess the evolving implications of the IRA on pricing, reimbursement, and research incentives.
Previous wording
Comparison for the nine months ended September 30, 2025 and 2024
Current wording
Comparison for the three months ended March 31, 2026 and 2025
Previous wording
The following table summarizes the Company’s operations results to the items outlined in the table for the three months ended September 30, 2025 and 2024, together with the change in such items in dollars and as a percentage.
Current wording
The following table summarizes the Company’s results of operations with respect to the items set forth in such table for the three months ended March 31, 2026 and 2025, together with the change in such items in dollars and as a percentage.
Previous wording
Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales for the three months ended September 30, 2025 and 2024, were as follows:
Current wording
Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced in order to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales for the three months ended March 31, 2026 and 2025, were as follows:
Previous wording
Our gross product revenues were $4.0 million and $4.0 million for the three months ended September 30, 2025 and 2024, respectively. These periods reflect revenue from the sale of our human drug Mytesi and our animal products branded as Canalevia-CA1, Neonorm Calf and Neonorm Foal.
Current wording
Our gross product revenues were approximately $1.3 million and $3.2 million for the three months ended March 31, 2026 and 2025, respectively. These figures reflect revenue from the sale of our human drug Mytesi, our animal products branded as Neonorm Calf and Neonorm Foal and exclusive distribution agreement for the sale of Gelclair.
Previous wording
Sales returns were $21,000 and $161,000 for the nine months ended September 30, 2025 and 2024, respectively, a decrease of $140,000, relative to the decrease in volume of sales returns.
Current wording
Sales returns were $0 and $17,000 for the three months ended March 31, 2026 and 2025, respectively, a decrease of $17,000 due to the decrease in volume of sales returns.
Previous wording
License revenues increased by $43,000 from $85,000 for the nine months ended September 30, 2024, to $128,000 in the same period in 2025, due to license agreement entered by the Company with Gen on March 18, 2024. The license revenue is recognized as the Licensee receives and consumes the benefits from the Company’s performance of providing access to its intellectual property evenly over the license period of five years.
Current wording
License revenues increased by $19.0 million from $43,000 for the three months ended March 31, 2025 to $19.0 million in the same period in 2026, due to license agreement entered by the Company with Woodward on January 12, 2026. The license revenue is recognized as Woodward receives and consumes the benefits from the Company’s performance of providing access to its intellectual property at point in time.
Previous wording
The decrease in R&D expense of $385,000 for the three months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Current wording
The increase in R&D expense of $198,000 for the three months ended March 31, 2026, compared to 2025 was primarily due to:
Previous wording
Third-party consulting services decreased by $363,000 from $773,000 in the three months ended September 30, 2024, to $410,000 in the same period in 2025 primarily due to lower consulting engagements following the conclusion of the CTD Phase 3 On Target Clinical Trial.
Current wording
Third-party consulting services decreased by $239,000 from $560,000 for the three months ended March 31, 2025 to $321,000 in the same period in 2026, as the Phase 3 On Target Clinical Trial concluded, reducing the consulting and contractor expenses.
Previous wording
The decrease in R&D expense of $1.4 million for the nine months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Current wording
The increase in R&D expense of $198,000 for the three months ended March 31, 2026 compared to 2025 was primarily due to:
Previous wording
The following table presents the components of sales and marketing (“S&M”) expense for the nine months ended September 30, 2025 and 2024, together with the change in such components in dollars and as a percentage:
Current wording
The following table presents the components of sales and marketing (“S&M”) expense for the three months ended March 31, 2026 and 2025, together with the change in such components in dollars and as a percentage:
Previous wording
The decrease in S&M expense of $13,000 for the three months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Current wording
The decrease in S&M expense of $1.6 million for the three months ended March 31, 2026, compared to the same period in 2025 was largely due to:
Previous wording
The following table presents the components of general and administrative (“G&A”) expense for the nine months ended September 30, 2025 and 2024, together with the change in such components in dollars and as a percentage:
Current wording
The following table presents the components of general and administrative (“G&A”) expense for the three months ended March 31, 2026 and 2025, together with the change in such components in dollars and as a percentage:
Previous wording
The increase in G&A expenses of $358,000 for the three months ended September 30, 2025, compared to the same period in 2024 was largely due to:
Current wording
The decrease in G&A expenses of $789,000 for the three months ended March 31, 2026, compared to the same period in 2025 was largely due to:
Previous wording
The changes in fair value of financial instruments and hybrid instrument designated at FVO decreased by $781,000, from a loss of $3.1 million in the three months ended September 30, 2024, to a loss of $2.3 million in the same period in 2025 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Current wording
The fair value of financial instrument and hybrid instrument designated at FVO decreased by $1.0 million, from a loss of $1.3 million in the three months ended March 31, 2025, to a loss of $337,000 in the same period in 2026 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Showing the first 40 of 49 pairs. Open the source sections for the rest.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth. It coats and protects the oral mucosa, which supports healing. Gelclair is convenient and easy to use, provides rapid and long-lasting pain relief, and improves the ability of oral mucositis patients to eat, drink, and swallow. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth.
Current report — wording carried from elsewhere
Change in Fair Value of Financial Instruments and Hybrid Instrument Designated at Fair Value Option
Current report — wording carried from elsewhere
Change in Fair Value of Financial Instruments and Hybrid Instrument Designated at FVO
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
Jaguar was founded in San Francisco, California as a Delaware corporation on June 6, 2013 (inception). The Company was previously a majority-owned subsidiary of Napo until the close of the Company’s initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class prescription and non-prescription products for companion animals.
Previous report — wording carried elsewhere
MVID is an ultrarare pediatric disease, with an estimated prevalence of a couple of hundred patients globally.
Previous report — wording carried elsewhere
As announced, the Company plans to pursue approval from the EMA’s Committee for Veterinary Medicinal Products (“CVMP”) for Canalevia in the European Union for treatment of general diarrhea in dogs.
Previous report — wording carried elsewhere
Due to the Company’s arrangements, including elements of variable consideration, gross product sales are reduced to reflect the expected consideration to arrive at net product sales. Deductions to reduce gross product sales to net product sales for the nine months ended September 30, 2025 and 2024, were as follows:
Previous report — wording carried elsewhere
The changes in fair value of financial instrument and hybrid instruments designated at FVO decreased by $2.2 million, from a loss of $6.9 million in the nine months ended September 30, 2024, to a loss of $4.7 million in the same period in 2025 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Previous report — wording carried elsewhere
Gain (Loss) on Extinguishment of Debt
Previous report — wording carried elsewhere
The following table presents the components of G&A expense for the three months ended September 30, 2025 and 2024, together with the change in such components in dollars and as a percentage: