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What changed in Jaguar Health, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Jaguar Health, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+550 added−480 removedSource: 10-K (2026-04-07) vs 10-K (2025-03-31)

Top changes in Jaguar Health, Inc.'s 2025 10-K

550 paragraphs added · 480 removed · 304 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

109 edited+49 added−107 removed199 unchanged
Biggest changeWith support provided by concomitant marketing, promotional activities, patient empowerment programs, including an integrated social digital campaign, and medical education initiatives described below, we expect a proportional response in the number of patients treated with Mytesi. 13 Table of Contents Leverage our relationships with Scientific Advisory Board (SAB) members for crofelemer commercialization and development in follow-on indications The Company has retained several subject matter experts and KOLS as its SAB members across the therapeutic areas of HIV, CTD, gastrointestinal disorders, SBS, and/or CDD.
Biggest changeLeverage our relationships with Scientific Advisory Board (SAB) members for crofelemer commercialization and development in follow-on indications The Company has retained several subject matter experts and KOLS as its SAB members across the therapeutic areas of gastrointestinal disorders, including MVID and SBS-IF. 8 Table of Contents Establish partnerships to support moving pipeline indications to pivotal clinical trials The Company’s goal is to establish partnerships to support the development and commercialization of the novel lyophilized crofelemer powder for oral solution for the indications of MVID and SBS-IF in the US and/or other geographies.
Napo completed its requisite preclinical and formulation activities to support the IND application for its second-generation, plant-based oral prescription drug product, NP-300, for its 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.
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.
Napo grants license to Napo Therapeutics In August 2021, Napo signed a license agreement with Napo Therapeutics to study, develop, manufacture, and commercialize Napo’s plant-based crofelemer and NP-300 drug product candidates in the European Union (excluding Russia) and in specified non-EU countries in Europe for specific indications, which rights and obligations were assumed by the combined company formed by the merger of Napo EU S.p.A. with Dragon SPAC (the combined company uses the Napo Therapeutics name).
Napo License to Napo Therapeutics In August 2021, Napo signed a license agreement with Napo Therapeutics to study, develop, manufacture, and commercialize Napo’s plant-based crofelemer and NP-300 drug product candidates in the European Union (excluding Russia) and in specified non-EU countries in Europe for specific indications, which rights and obligations were assumed by the combined company formed by the merger of Napo EU S.p.A. with Dragon SPAC (the combined company uses the Napo Therapeutics name).
In addition, an NP-300 is in development for symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, caused by bacterial, viral, and parasitic infections, including Vibrio cholerae , the bacterium that causes cholera. Our management team collectively has extensive experience in the development of prescription drugs.
In addition, an NP-300 is in development for symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, caused by bacterial, viral, and parasitic infections, including Vibrio cholerae , the bacterium that causes cholera. Our management team has extensive experience in the development of prescription drugs.
For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to the utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs covered under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; creation of the Independent Payment Advisory Board, once empaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and establishment of a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to the utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs covered under Medicare Part 27 Table of Contents D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; creation of the Independent Payment Advisory Board, once empaneled, will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs; and establishment of a Center for Medicare Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
A growing percentage of HIV patients have lived with the virus in their gut for 10+ years, often causing gut enteropathy and chronic or chronic episodic diarrhea.
A growing percentage of HIV patients have lived with the virus in their guts for 10+ years, often causing gut enteropathy and chronic or chronic episodic diarrhea.
EMA Grants The EMA does not offer research grants for sponsors of orphan medicines, but funding is available from the European Commission and other sources: • Horizon 2020, the EU Framework Programme for Research and Innovation • E-Rare, a transnational project for research programs on rare diseases • Grants are also available for sponsors considering research in the US or Japan • US: Food and Drug Administration: Orphan products grants program • Japan: National Institute of Biomedical Innovation: Services to promote development of medicinal products for rare diseases Incentives in Member States Details on incentives available for designated orphan medicines in EU Member States are available in the European Commission's Inventory of Union and Member State incentives to support research into and the development and availability of orphan medicinal products.
EMA Grants The EMA does not offer research grants for sponsors of orphan medicines, but funding is available from the European Commission and other sources: • Horizon 2020, the EU Framework Programme for Research and Innovation • E-Rare, a transnational project for research programs on rare diseases 19 Table of Contents • Grants are also available for sponsors considering research in the US or Japan • US: Food and Drug Administration: Orphan products grants program • Japan: National Institute of Biomedical Innovation: Services to promote development of medicinal products for rare diseases Incentives in Member States Details on incentives available for designated orphan medicines in EU Member States are available in the European Commission's Inventory of Union and Member State incentives to support research into and the development and availability of orphan medicinal products.
Criteria and conditions EMA's CHMP may grant conditional marketing authorization for medicine if it finds that all of the following criteria are met: • the benefit-risk balance of the medicine is positive; • it is likely that the applicant will be able to provide comprehensive data post-authorization; • the medicine fulfills an unmet medical need; and • the benefit of the medicine's immediate availability to patients is greater than the risk inherent in requiring additional data.
Criteria and conditions EMA's CHMP may grant conditional marketing authorization for medicine if it finds that all of the following criteria are met: • the benefit-risk balance of the medicine is positive; 17 Table of Contents • it is likely that the applicant will be able to provide comprehensive data post-authorization; • the medicine fulfills an unmet medical need; and • the benefit of the medicine's immediate availability to patients is greater than the risk inherent in requiring additional data.
These include: • full prescribing information and package leaflet with detailed instructions for safe use and conditions for storage; • a robust risk-management and safety monitoring plan; • manufacturing controls, including official batch controls for vaccines, as required; 23 Table of Contents • legally binding post-approval obligations (i.e., conditions) for the marketing authorization holder and a clear legal framework for the evaluation of emerging efficacy and safety data; • a pediatric investigation plan.
These include: • full prescribing information and package leaflet with detailed instructions for safe use and conditions for storage; • a robust risk-management and safety monitoring plan; • manufacturing controls, including official batch controls for vaccines, as required; • legally binding post-approval obligations (i.e., conditions) for the marketing authorization holder and a clear legal framework for the evaluation of emerging efficacy and safety data; • a pediatric investigation plan.
The Company has previously presented Phase 2 data on crofelemer for the treatment of diarrhea in cholera patients from a study in Bangladesh. Napo plans to follow a similar clinical study design to support the development of NP-300 for a cholera-related indication.
Since the Company previously presented Phase 2 data on crofelemer for the treatment of diarrhea in cholera patients from a study in Bangladesh, Napo plans to follow a similar clinical study design to support the development of NP-300 for a cholera-related indication.
The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains 27 Table of Contents an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
We expect that NP-300 will be significantly less expensive and would support development efforts to receive a tropical disease priority review voucher 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.
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.
Violations of fraud and abuse laws, including federal and state Anti-Kickback and false claims laws, may be punishable by criminal and civil sanctions, including fines and civil monetary penalties, the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid), disgorgement and corporate integrity 29 Table of Contents agreements, which impose, among other things, rigorous operational and monitoring requirements on companies.
Violations of fraud and abuse laws, including federal and state Anti-Kickback and false claims laws, may be punishable by criminal and civil sanctions, including fines and civil monetary penalties, the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid), disgorgement and corporate integrity agreements, which impose, among other things, rigorous operational and monitoring requirements on companies.
Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune and viral diseases. 22 Table of Contents Conditional marketing authorization The EMA supports the development of medicines that address unmet medical needs.
Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune and viral diseases. Conditional marketing authorization The EMA supports the development of medicines that address unmet medical needs.
Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorization for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004. Distinction from authorization under exceptional circumstances EMA may also grant marketing authorization in the absence of comprehensive data under exceptional circumstances.
Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorization for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004. 18 Table of Contents Distinction from authorization under exceptional circumstances EMA may also grant marketing authorization in the absence of comprehensive data under exceptional circumstances.
The FDCA defines a new animal drug (in part) as any drug intended for use for animals other than man, the composition of which is not generally recognized among experts qualified by scientific training and 30 Table of Contents experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
The FDCA defines a new animal drug (in part) as any drug intended for use for animals other than man, the composition of which is not generally recognized among experts qualified by scientific training and experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
In addition, certain states require the implementation of compliance programs and compliance with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, impose restrictions on marketing practices and/or tracking and reporting of gifts, compensation and other remuneration or items of value provided to physicians and other healthcare professionals and entities.
In addition, 24 Table of Contents certain states require the implementation of compliance programs and compliance with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, impose restrictions on marketing practices and/or tracking and reporting of gifts, compensation and other remuneration or items of value provided to physicians and other healthcare professionals and entities.
Indexing is allowed for drugs for: • Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals are typically not eaten by people or by other animals that produce food for people to eat, and 31 Table of Contents • An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters).
Indexing is allowed for drugs for: • Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals are typically not eaten by people or by other animals that produce food for people to eat, and • An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters).
Clinical Trials for Human Prescription Drugs Clinical trials involve the administration of the investigational new drug to human subjects pursuant to a clinical protocol under the supervision of qualified investigators in accordance with GCPs requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial.
Clinical Trials for Human Prescription Drugs Clinical trials involve the administration of the investigational new drug to human subjects pursuant to a clinical protocol under the supervision of qualified investigators in accordance with GCPs requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in 13 Table of Contents any clinical trial.
Importantly a greater proportion of patients with breast cancer randomized to 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 CTD diarrhea in adult patients with breast cancer receiving targeted therapies with or without chemotherapy .
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.
More recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills 33 Table of Contents designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.
More recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.
Napo also has patent families related to methods of treating diarrhea-predominant irritable bowel syndrome, methods of treating constipation-predominant irritable bowel syndrome, and methods of treating inflammatory bowel disease, familial adenomatous polyposis, and colon cancer, with proanthocyanidin polymers isolated from Croton spp. or Calophyllum spp., including crofelemer.
Napo also has patent families related to methods of treating diarrhea-predominant irritable bowel syndrome, methods of treating 11 Table of Contents constipation-predominant irritable bowel syndrome, and methods of treating inflammatory bowel disease, familial adenomatous polyposis, and colon cancer, with proanthocyanidin polymers isolated from Croton spp. or Calophyllum spp., including crofelemer.
Transfers of orphan designation from one sponsor to another are possible. Transfers are free of charge. Sponsors can also request removal of an orphan designation. 25 Table of Contents EMA Compassionate Use Program Compassionate use is a treatment option that allows the use of an unauthorized medicine.
Transfers of orphan designation from one sponsor to another are possible. Transfers are free of charge. Sponsors can also request removal of an orphan designation. EMA Compassionate Use Program Compassionate use is a treatment option that allows the use of an unauthorized medicine.
The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to ensure the product’s continued safety, quality, and purity. 20 Table of Contents The FDA may refer an application for a novel drug to an advisory committee.
The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to ensure the product’s continued safety, quality, and purity. The FDA may refer an application for a novel drug to an advisory committee.
In addition, advertising and promotion of animal health products are controlled by regulations in many countries. These rules generally restrict advertising and promotion to those claims and uses that have been reviewed and approved by the applicable agency.
In addition, advertising and promotion of animal health products are controlled by regulations in many countries. These rules generally restrict advertising and 26 Table of Contents promotion to those claims and uses that have been reviewed and approved by the applicable agency.
The recently conducted global OnTarget clinical trial was a 24-week (two 12-week stages), randomized, multicenter, placebo-controlled, double-blind 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.
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.
Accordingly, manufacturers must continue to expend time, money, and effort in production and quality control to maintain cGMP compliance. 21 Table of Contents Once approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Accordingly, manufacturers must continue to expend time, money, and effort in production and quality control to maintain cGMP compliance. Once approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Description of Properties Our corporate headquarters are located in San Francisco, California, where we currently lease 10,998 rentable square feet of office space from M & E, LLC.
Description of Properties Our corporate headquarters are located in San Francisco, California, where we currently lease 10,998 rentable square feet of office space from M & E, LLC. 29 Table of Contents
Three Regulatory Pathways in the US to Legal Marketing Status for Animal Health Drugs Approval An approved animal drug has gone through the NADA process or the ANADA process for an approved generic animal drug. If the information in the application meets the requirements for approval, FDA approves the animal drug.
Three Regulatory Pathways in the US to Legal Marketing Status for Animal Health Drugs Approval An approved animal drug has gone through the NADA process or the ANADA process for an approved generic animal drug. If the information in the application meets the requirements for approval, FDA approves the 25 Table of Contents animal drug.
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”).
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 1 Table of Contents wholly owned subsidiary (the “Merger” or “Napo Merger”).
This venture aligns with Jaguar's ETI program 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.
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.
As previously announced, while the initial top line results from the OnTarget study showed that the clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types and all targeted therapies. However, in the prespecified subgroup of patients with breast cancer, Crofelemer showed statistically significant improvement in the monthly responder analysis.
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.
Jaguar Animal Health is a trademark owned by Jaguar. 16 Table of Contents License Agreements Patent Portfolio Napo Napo owns a portfolio of patents and patent applications covering formulations of and treatment methods with proanthocyanidin polymers isolated from Croton spp. or Calophyllum spp., including Mytesi (crofelemer).
Jaguar Animal Health is a trademark owned by Jaguar. Patent Portfolio Napo Napo owns a portfolio of patents and patent applications covering formulations of and treatment methods with proanthocyanidin polymers isolated from Croton spp. or Calophyllum spp., including Mytesi (crofelemer).
To accomplish this goal, we plan to: Expand Mytesi by leveraging our significant gastrointestinal product knowledge, experience and intellectual property portfolio Mytesi (crofelemer 125 mg delayed-release tablets) is a novel, first-in-class anti-secretory antidiarrheal agent which has a normalizing effect on the electrolyte and fluid balance in the gut, and this mechanism of action has the potential to benefit multiple gastrointestinal disorders.
To accomplish this goal, we plan to: Expand Mytesi by leveraging our significant gastrointestinal product knowledge, experience and intellectual property portfolio Mytesi (crofelemer 125 mg delayed-release tablets), licensed to Future Pak in January 2026 for US distribution and commercialization, is a novel, first-in-class anti-secretory antidiarrheal agent which has a normalizing effect on the electrolyte and fluid balance in the gut, and this mechanism of action has the potential to benefit multiple gastrointestinal disorders.
Strategically sequence the development of follow-on indications of Mytesi and seek geographically focused licensing opportunities As announced April 1, 2022, the Company has entered an agreement with Quadri Pharmaceuticals Store LLC (“Quadri Pharma”) that grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of Mytesi (crofelemer 125 mg delayed-release tablets) in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates (“UAE”), and Oman following regulatory approval to market crofelemer in these countries for the specified indications, including the indication currently approved in the US for HIV-related diarrhea.
As announced April 1, 2022, the Company entered an agreement with Quadri Pharmaceuticals Store LLC (“Quadri Pharma”) that grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of Mytesi (crofelemer 125 mg delayed-release tablets) in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates (“UAE”), and Oman following regulatory approval to market crofelemer in these countries for the specified indications, including the indication currently approved in the US for HIV-related diarrhea.
The tree is found in several South American countries and has been the focus of long-term sustainable harvesting research and development work. Napo’s collaborating suppliers obtain CPL and arrange for the shipment of CPL to Napo’s third-party contract manufacturer. Napo’s third-party contract manufacturer, India-based Glenmark Life Sciences Ltd.
The tree is found in several South American countries and has been the focus of long-term sustainable harvesting research and development work. Napo’s collaborating suppliers obtain CPL and arrange for the shipment of CPL to Napo’s third-party contract manufacturer.
Multiple sites may necessitate the involvement of multiple IRBs and submissions for human health products; • performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCPs”), requirements to establish the safety and efficacy of the proposed drug product for each indication; • submission to the FDA of an NDA for marketing approval of human prescription drugs; • satisfactory completion of FDA advisory committees review, if applicable; • satisfactory completion of an FDA pre-approval inspection (“PAI”) of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practices (“cGMPs”), requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and • FDA review and approval of the NDA. 18 Table of Contents Pre-clinical Studies Pre-clinical studies include laboratory evaluation of the drug product’s chemistry, toxicity, and formulation and animal studies to assess potential safety and effectiveness.
Multiple sites may necessitate the involvement of multiple IRBs and submissions for human health products; • performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCPs”), requirements to establish the safety and efficacy of the proposed drug product for each indication; • submission to the FDA of an NDA for marketing approval of human prescription drugs; • satisfactory completion of FDA advisory committees review, if applicable; • satisfactory completion of an FDA pre-approval inspection (“PAI”) of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practices (“cGMPs”), requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and • FDA review and approval of the NDA.
In April 2014, the EU adopted a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials Directive 2001/20/EC. It is anticipated that the new Clinical Trials Regulation (EU) No 536/2014 may come into effect in late 2021 with a three-year transition period for some types of clinical trials.
In April 2014, the EU adopted a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials Directive 2001/20/EC. The new Clinical Trials Regulation (EU) No 536/2014 took effect in late 2021 with a three-year transition period for some types of clinical trials.
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.
If a drug is designated as breakthrough therapy, the FDA will expedite the review timeline for the drug. 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.
Other potential consequences include, include, but are not limited to: • restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; • fines, warning letters or holds on post-approval clinical trials; • refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals; • product seizure or detention, or refusal to permit the import or export of products; or • injunctions or the imposition of civil or criminal penalties.
Other potential consequences include, but are not limited to: • restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; • fines, warning letters or holds on post-approval clinical trials; • refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals; • product seizure or detention, or refusal to permit the import or export of products; or • injunctions or the imposition of civil or criminal penalties. 16 Table of Contents The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market.
Our voting common stock is listed on the Nasdaq Capital Market and trades under the symbol “JAGX.” On July 31, 2017, we completed the acquisition of Napo pursuant to the Agreement and Plan of Merger, dated March 31, 2017, by and among the Company, Napo, Napo Acquisition Corporation, and Napo’s representative (the “Merger”). 34 Table of Contents Employees As of December 31, 2024, we had forty-nine employees.
Our voting common stock is listed on the Nasdaq Capital Market and trades under the symbol “JAGX.” On July 31, 2017, we completed the acquisition of Napo pursuant to the Agreement and Plan of Merger, dated March 31, 2017, by and among the Company, Napo, Napo Acquisition Corporation, and Napo’s representative (the “Merger”).
Even if the FDA agrees to the design, execution, and analyses proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement under the following circumstances: • public health concerns emerged that were unrecognized at the time of the protocol assessment; • the director of the review division determines that a substantial scientific issue essential to determining safety or efficacy has been identified after testing has begun; • a sponsor fails to follow a protocol that was agreed upon with the FDA; or • the relevant data, assumptions, or information provided by the sponsor in a request for SPA change, are found to be false statements or misstatements or are found to omit relevant facts.
Even if the FDA agrees to the design, execution, and analyses proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement under the following circumstances: • public health concerns emerged that were unrecognized at the time of the protocol assessment; • the director of the review division determines that a substantial scientific issue essential to determining safety or efficacy has been identified after testing has begun; • a sponsor fails to follow a protocol that was agreed upon with the FDA; or • the relevant data, assumptions, or information provided by the sponsor in a request for SPA change, are found to be false statements or misstatements or are found to omit relevant facts. 14 Table of Contents A documented SPA may be modified, and such modification will be deemed binding on the FDA review division, except under the circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is intended to improve the study.
Even with the submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Even with the submission of this additional information, the FDA ultimately may decide 15 Table of Contents that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter.
Intellectual Property Trademarks We plan to market all of our products under a trademark or trademarks we select, and we will own all rights, title and interest, including all goodwill, associated with such trademarks. Mytesi is a registered trademark owned by Napo.
Proprietary Library of Medicinal Plants We possess a proprietary library of more than 2,300 medicinal plants. Intellectual Property Trademarks We plan to market all of our products under a trademark or trademarks we select, and we will own all rights, title and interest, including all goodwill, associated with such trademarks. Mytesi is a registered trademark owned by Napo.
Our portfolio development strategy is based on identifying indications that are potentially high value because they address important medical needs that are significantly or globally unmet, and then strategically sequencing indication development priorities, second-generation product pipeline development, and partnering goals on a global basis.
Our portfolio development strategy is based on identifying indications that are potentially high value because they address important medical needs that are significantly or globally unmet, and then strategically sequencing indication development priorities, second-generation product pipeline development, and partnering goals on a global basis. Competition Several significantly larger pharmaceutical companies are competing with us in the gastrointestinal segment.
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.
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. Napo’s crofelemer 125 mg delayed-release tablets (Mytesi) is an FDA (the U.S.
The above can be complemented by other incentives to support the research, development and availability of medicinal products for pediatric use. Market exclusivity: Orphan medicines Orphan medicines benefit from ten years of market exclusivity once they receive marketing authorization in the EU.
If a PUMA is granted, the product will benefit from 10 years of market protection as an incentive. The above can be complemented by other incentives to support the research, development and availability of medicinal products for pediatric use. Market exclusivity: Orphan medicines Orphan medicines benefit from ten years of market exclusivity once they receive marketing authorization in the EU.
Twelve employees hold M.D., D.V.M and/or Ph.D. degrees. Twenty-two of our employees are in research and development activities, and seventeen are in sales and marketing. We have four employees within Napo Therapeutics in Italy. Our employees are not represented by labor unions or covered by collective bargaining agreements.
Employees As of December 31, 2025, we had forty-seven employees. Nine employees hold M.D., D.V.M and/or Ph.D. degrees. Seventeen of our employees are in research and development activities, and eighteen are in sales and marketing. We have four employees within Napo Therapeutics in Italy. Our employees are not represented by labor unions or covered by collective bargaining agreements.
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.
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.
Each indication with an orphan designation confers ten years of market exclusivity for the particular indication. A medicine that has multiple orphan designations for different conditions will benefit from separate market exclusivity periods pertaining to its different orphan designations. To benefit from market exclusivity, a medicine must maintain its orphan designation at the time of marketing authorization.
A medicine that has multiple orphan designations for different conditions will benefit from separate market exclusivity periods pertaining to its different orphan designations. 21 Table of Contents To benefit from market exclusivity, a medicine must maintain its orphan designation at the time of marketing authorization.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. In addition, the FDA regulates the purity and or consistency of the approved product.
Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.
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. 2 Table of Contents 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.
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.
European Union Pediatric Plan In the EEA, marketing authorization applications for new medicinal products not authorized have to include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan, or PIP, agreed with the EMA’s Pediatric Committee (“PDCO”).
ODD does not convey any advantage in or shorten the duration of the regulatory review and approval process. 22 Table of Contents European Union Pediatric Plan In the EEA, marketing authorization applications for new medicinal products not authorized have to include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan, or PIP, agreed with the EMA’s Pediatric Committee (“PDCO”).
Jaguar family company Napo Therapeutics, S.p.A is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe, specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename.
Jaguar family companies Napo and Napo Therapeutics, S.p.A., an Italian corporation Jaguar was 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.
In the US, Takeda Pharmaceuticals’ GATTEX ® (teduglutide) is indicated for treating adults and pediatric patients 1 year of age and older with SBS dependent on parenteral support. Zorbtive ® is a recombinant human growth hormone indicated for the treatment of SBS in adult patients receiving specialized nutritional support.
In the US, Takeda Pharmaceuticals commercializes GATTEX (teduglutide), which is glucagon-like peptide-2 (GLP-2), a growth hormone. Teduglutide is approved by the FDA for treating adults and pediatric patients with SBS dependent on parenteral support (PS). Zorbtive is a recombinant human growth hormone indicated for the treatment of SBS in adult patients receiving specialized nutritional support.
Additionally, the intent standard under the US federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the ACA, to a stricter standard such that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare-covered business, the statute has been violated. 23 Table of Contents Additionally, the intent standard under the US federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the ACA, to a stricter standard such that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
The license agreement grants Napo Therapeutics the rights for SBS-IF, HIV-related diarrhea, and the symptomatic relief and treatment of IF-related diarrhea in patients with congenital disorders. 17 Table of Contents Government Regulation The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of prescription drugs such as those that Jaguar and its subsidiaries are commercializing and/or developing.
Government Regulation The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of prescription drugs such as those that Jaguar and its subsidiaries are commercializing and/or developing.
Products, if deemed adulterated, can lead to serious consequences, as set forth above as well as civil and criminal penalties. EMA Regulation of Human Prescription Drugs Napo and Napo Therapeutics intend to leverage the orphan medicines marketing authorization incentives from the EMA for the SBS and CDD indications for crofelemer for the licensed territories in the European Union.
EMA Regulation of Human Prescription Drugs Napo and Napo Therapeutics intend to leverage the orphan medicines marketing authorization incentives from the EMA for the SBS and CDD indications for crofelemer for the licensed territories in the European Union.
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 San Antonio Breast Cancer Symposium (SABCS) in December 2024.
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.
An IND automatically becomes effective 30 days after receipt by the FDA unless, before that time, the FDA raises concerns or questions about one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.
Some pre-clinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA unless, before that time, the FDA raises concerns or questions about one or more proposed clinical trials and places the clinical trial on a clinical hold.
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.
FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS Act.
For instance, the new Clinical Trials Regulation provides for a streamlined application procedure via a single entry point and strictly defined deadlines for the assessment of clinical trial applications. 28 Table of Contents Other US Healthcare Laws In addition to FDA restrictions on the marketing of pharmaceutical and biological products, other US federal and state healthcare regulatory laws restrict business practices in the pharmaceutical industry, which include, but are not limited to, state and federal anti-kickback, false claims, data privacy and security and physician payment and drug pricing transparency laws.
Other US Healthcare Laws In addition to FDA restrictions on the marketing of pharmaceutical and biological products, other US federal and state healthcare regulatory laws restrict business practices in the pharmaceutical industry, which include, but are not limited to, state and federal anti-kickback, false claims, data privacy and security and physician payment and drug pricing transparency laws.
To comply with the regulatory requirements in each of the jurisdictions in which Napo is seeking to market and subsequently sell its prescription products, Napo has established processes and resources to provide oversight of the development, approval processes, and launch of its products and to position those products to gain market share.
To comply with the regulatory requirements in each of the jurisdictions in which Napo is seeking to market and subsequently sell its prescription products, Napo has established processes and resources to provide oversight of the development, approval processes, and launch of its products and to position those products to gain market share. 12 Table of Contents US Government Regulation Human Prescription Drugs In the US, the FDA approves and regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations.
In addition to the foregoing, we may be subject to state, federal, and foreign healthcare and/or veterinary medicine laws, including but not limited to anti-kickback laws, as we may, from time to time, enter consulting and other financial arrangements with veterinarians, who may prescribe or recommend our products.
We do not believe that our non-prescription products fit the definition of an animal drug, food, or food additive and, therefore are not regulated by the FDA at this time. 28 Table of Contents In addition to the foregoing, we may be subject to state, federal, and foreign healthcare and/or veterinary medicine laws, including but not limited to anti-kickback laws, as we may, from time to time, enter consulting and other financial arrangements with veterinarians, who may prescribe or recommend our products.
This was a key milestone in the ongoing process of establishing Indena as an additional approved crofelemer manufacturer as we work to support the increased crofelemer manufacturing demand expected upon potential FDA approval of crofelemer for new indications, including approval for CTD. Proprietary Library of Medicinal Plants We possess a proprietary library of more than 2,300 medicinal plants.
Resultingly, batches of crofelemer API manufactured by Indena can now be used by Jaguar for further development work. This was a key milestone in the ongoing process of establishing Indena as an additional approved crofelemer manufacturer as we work to support the increased crofelemer manufacturing demand expected upon potential FDA approval of crofelemer for new indications, including approval for CTD.
Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial conduct, and data analysis within 45 days of receipt of the request. 19 Table of Contents The FDA ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of the product candidate with respect to the effectiveness of the indication studied.
Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial conduct, and data analysis within 45 days of receipt of the request.
Net Sales Exceed $1 Billion in 2021 (https://investor.ironwoodpharma.com/press-releases/press-release-details/2022/Ironwood-Pharmaceuticals-Reports-Fourth-Quarter-and-Full-Year-2021-Results-LINZESS-linaclotide-Achieves-Blockbuster-Status-as-U.S.-Net-Sales-Exceed-1-Billion-in-2021/default.aspx); Rodman & Renshaw estimate peak annual sales of Synergy Pharmaceuticals’ Trulance at $2.3 bn in 2021 (https://www.benzinga.com/analyst-ratings/analyst-color/17/04/9304883/what-synergys-new-patents-mean-for-its-commercial-prospe) (7) In Aug. 2015, AbbVie Inc. bought a priority review voucher from United Therapeutics Corp for $350 million (https://www.wsj.com/articles/united-therapeutics-sells-priority-review-voucher-to-abbvie-for-350-million-1439981104 ).
Form 10-K for the fiscal year ended December 31, 2016 7 Table of Contents (4) Report published by Allied Market Research, titled, "Chemotherapy-induced Nausea and Vomiting (CINV) Market-Global Opportunity Analysis and Industry Forecast, 2014-2022” ( https://www.prnewswire.com/news-releases/chemotherapy-induced-nausea-and-vomiting-cinv-market-expected-to-reach-2659-million-by-2022-611755395.html ) (5) Short Bowel Syndrome Market – Global Industry Analysis, Size, Share, Trends, Revenue, Forecast 2020 to 2027 ( https://www.mynewsdesk.com/us/medical-technology-news/pressreleases/short-bowel-syndrome-market-global-industry-analysis-size-share-trends-revenue-forecast-2020-to-2027-3069433 ) (6) February 17, 2022: Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results; LINZESS® (linaclotide) Achieves Blockbuster Status as US Net Sales Exceed $1 Billion in 2021 (https://investor.ironwoodpharma.com/press-releases/press-release-details/2022/Ironwood-Pharmaceuticals-Reports-Fourth-Quarter-and-Full-Year-2021-Results-LINZESS-linaclotide-Achieves-Blockbuster-Status-as-U.S.-Net-Sales-Exceed-1-Billion-in-2021/default.aspx); Rodman & Renshaw estimate peak annual sales of Synergy Pharmaceuticals’ Trulance at $2.3 bn in 2021 (https://www.benzinga.com/analyst-ratings/analyst-color/17/04/9304883/what-synergys-new-patents-mean-for-its-commercial-prospe) (7) In Aug. 2015, AbbVie Inc. bought a priority review voucher from United Therapeutics Corp for $350 million (https://www.wsj.com/articles/united-therapeutics-sells-priority-review-voucher-to-abbvie-for-350-million-1439981104 ).
In addition, in some countries, cross-border imports from low-priced markets exert commercial pressure on pricing within a country. The containment of healthcare costs has become a priority of federal, state, and foreign governments, and the prices of pharmaceutical or biological products have been a focus in this effort.
The containment of healthcare costs has become a priority of federal, state, and foreign governments, and the prices of pharmaceutical or biological products have been a focus in this effort.
Rewards and incentives for pediatric medicines Several rewards and incentives for the development of pediatric medicines for children are available in the EU. Medicines authorized across the EU with the results of studies from a pediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate by six months.
Medicines authorized across the EU with the results of studies from a pediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate by six months. This is the case even when the studies' results are negative. For orphan medicines, the incentive is an additional two years of market exclusivity.
Additionally, through the establishment of a nonprofit called the Healing Forest Conservancy, our team has created a long-term mechanism for benefit sharing that recognizes the intellectual contribution of Indigenous populations. This program intends to contribute to the continued strength and effectiveness of the valued and strategically important relationships we have cultivated over the past 30 years.
Our team continues to have relationships with partners that we began working within the 1990s. Additionally, through the establishment of a nonprofit called the Healing Forest Conservancy, our team has created a long-term mechanism for benefit sharing that recognizes the intellectual contribution of Indigenous populations.
The medicine must be undergoing clinical trials or have entered the marketing-authorization application process, and while early studies will generally have been completed, its safety profile and dosage guidelines may not be fully established.
The medicine must be undergoing clinical trials or have entered the marketing-authorization application process, and while early studies will generally have been completed, its safety profile and dosage guidelines may not be fully established. 20 Table of Contents How to request an opinion for Compassionate Use National competent authorities can ask EMA for an opinion on how to administer, distribute, and use certain medicines for compassionate use.
Our Mytesi (crofelemer) product is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar, through Napo and Napo Therapeutics, holds global unencumbered rights for Mytesi. Mytesi is in development for multiple possible follow-on indications, including prophylaxis of diarrhea related to targeted therapy with or without standard chemotherapy.
Our Mytesi (crofelemer) product is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar, through Napo and Napo Therapeutics, holds global unencumbered rights for Mytesi. Crofelemer powder for oral solution is being developed to treat the orphan and/or rare intestinal failure (IF) indications for pediatric MVID and adult SBS-IF indications.
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 2025 while the company pursues approval of crofelemer for SBS and MVID from the EMA and the FDA.
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.
As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
EMA does not update its recommendations after a medicine receives marketing authorization, as all relevant information on the medicine's use is available in its European Public Assessment Report (“EPAR”). However, compassionate use programs may continue in certain Member States until the medicine becomes available on the market.
Compassionate use recommendations EMA's recommendations cover how a medicine should be used in compassionate use programs across the EU, and the type of patient who may benefit from treatment. EMA does not update its recommendations after a medicine receives marketing authorization, as all relevant information on the medicine's use is available in its European Public Assessment Report (“EPAR”).
(“Indena”), a Milan, Italy-based contract manufacturer dedicated to the identification, development, and production of high-quality active principles derived from plants, for use in the pharmaceutical, health food, and personal care industries. Indena has completed the required validation activities to gain approval as a manufacturer of crofelemer drug substance.
Additionally, Napo is establishing a second processing site, which will be operated by Indena S.p.A. (“Indena”), a Milan, Italy-based contract manufacturer dedicated to the identification, development, and production of high-quality active principles derived from plants, for use in the pharmaceutical, health food, and personal care industries.
(“Glenmark”), a research-driven, global, integrated pharmaceutical company, is Napo’s manufacturer of crofelemer, the active pharmaceutical ingredient in Mytesi. Glenmark processes CPL into crofelemer utilizing a proprietary manufacturing process. The processing occurs at an FDA-approved Glenmark facility. Additionally, Napo is establishing a second processing site, which will be operated by Indena S.p.A.
Napo’s third-party contract manufacturer, India-based Alivus Life Sciences Limited (f/k/a Glenmark Life Sciences Limited) (“Alivus”), a research-driven, global, integrated pharmaceutical company, is Napo’s manufacturer of crofelemer, the active pharmaceutical ingredient in Mytesi. Alivus processes CPL into crofelemer utilizing a proprietary manufacturing process. The processing occurs at an FDA-approved Alivus facility.
As announced January 25, 2023, the required procedure of registering the source of the API of crofelemer with the Agenzia Italiana Del Farmaco (“AIFA”), the Italian Medicines Agency, has been successfully completed. Resultingly, batches of crofelemer API manufactured by Indena can now be used by Jaguar for further development work.
Indena has completed the required validation activities to gain approval as a manufacturer of crofelemer drug substance. As announced January 25, 2023, the required procedure of registering the source of the API of crofelemer with the Agenzia Italiana Del Farmaco (“AIFA”), the Italian Medicines Agency, has been successfully completed.
An IND sponsor must submit the results of the pre-clinical tests, manufacturing information, analytical data, and any available clinical data or literature, among other things, to the FDA as part of an IND. Some pre-clinical testing may continue even after the IND is submitted.
Pre-clinical Studies Pre-clinical studies include laboratory evaluation of the drug product’s chemistry, toxicity, and formulation and animal studies to assess potential safety and effectiveness. An IND sponsor must submit the results of the pre-clinical tests, manufacturing information, analytical data, and any available clinical data or literature, among other things, to the FDA as part of an IND.
US Government Regulation Human Prescription Drugs In the US, the FDA approves and regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local, and foreign statutes and regulations requires substantial time and financial resources.
The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local, and foreign statutes and regulations requires substantial time and financial resources.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Related to Our Intellectual Property • We cannot be certain that our patent strategy will be effective in protecting against competition. • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, which would be costly and time-consuming and, if successfully asserted against us, delay or prevent the development and commercialization of our current or future products and product candidates. • Our proprietary position depends upon the botanical guidance of our drug approval and patents that are formulation or method-of-use patents, which do not prevent a competitor from using the same human or animal drug for another use. • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming, and unsuccessful, and third parties may challenge the validity or enforceability of our patents, and they may be successful. • If we are unable to prevent disclosure of our trade secrets or other confidential information to third parties, our competitive position may be impaired. • Changes in US patent law could diminish the value of patents in general, thereby impairing our ability to protect our products. • We may not be able to protect our intellectual property rights throughout the world, which could impair our business. • Our business could be harmed if we fail to obtain certain registered trademarks in the US or in other countries. • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential third-party information. • Even if we receive any of the required regulatory approvals for our current or future prescription drug product candidates and non-prescription products, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses. • Any of our current or future prescription drug product candidates or non-prescription products may cause or contribute to adverse medical events that we would be required to report to regulatory authorities and if we fail to do so, we could be subject to sanctions that would harm our business. • Legislative or regulatory reforms with respect to animal health may make it more difficult and costly for us to obtain regulatory clearance or approval for any of our current or future product candidates and to produce, market, and distribute our products after clearance or approval is obtained. • We believe that our non-prescription products are not subject to regulation by regulatory agencies in the US, but there is a risk that regulatory bodies may disagree with our interpretation or may redefine the scope of their regulatory reach in the future, which would result in additional expense and could delay or prevent the commercialization of these products. 38 Table of Contents • Even if we receive the required regulatory approvals for our current or future prescription drug product candidates and non-prescription products, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expenses.
Biggest changeRisks Related to Our Intellectual Property • We cannot be certain that our patent strategy will be effective in protecting against competition. • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, which would be costly and time-consuming and, if successfully asserted against us, delay or prevent the development and commercialization of our current or future products and product candidates. • Our proprietary position depends upon the botanical guidance of our drug approval and patents that are formulation or method-of-use patents, which do not prevent a competitor from using the same human or animal drug for another use.
Factors that may have contributed to such volatility include but are not limited to, those discussed previously in this “Risk Factors” section of this report and others, such as: • delays in the commercialization of Mytesi, Canalevia-CA1, or our other current or future prescription drug product candidates and non-prescription products; • any delays in, or suspension or failure of, our current and future studies; • announcements of regulatory approval or disapproval of any of our current or future product candidates or of regulatory actions affecting our company or our industry; • manufacturing and supply issues that affect product candidate or product supply for our studies or commercialization efforts; 64 Table of Contents • quarterly variations in our results of operations or those of our competitors; • changes in our earnings estimates or recommendations by securities analysts; • the payment of licensing fees or royalties in shares of our common stock; • announcements by us or our competitors of new prescription drug products or product candidates or non-prescription products, significant contracts, commercial relationships, acquisitions or capital commitments; • announcements relating to future development or license agreements including termination of such agreements; • adverse developments with respect to our intellectual property rights or those of our principal collaborators; • commencement of litigation involving us or our competitors; • any major changes in our board of directors or management; • new legislation in the US relating to the prescription, sale, distribution or pricing of gastrointestinal health products; • product liability claims, other litigation or public concern about the safety of our prescription drug product or product candidates and non-prescription products or any such future products; • market conditions in the human or animal industry, in general, or in the gastrointestinal health sector, in particular, including performance of our competitors; • future issuances of shares of common stock or other securities; • general economic conditions in the US and abroad; and • market speculation regarding any of the foregoing.
Factors that may have contributed to such volatility include but are not limited to, those discussed previously in this “Risk Factors” section of this report and others, such as: • delays in the commercialization of Mytesi, Canalevia-CA1, or our other current or future prescription drug product candidates and non-prescription products; • any delays in, or suspension or failure of, our current and future studies; • announcements of regulatory approval or disapproval of any of our current or future product candidates or of regulatory actions affecting our company or our industry; • manufacturing and supply issues that affect product candidate or product supply for our studies or commercialization efforts; • quarterly variations in our results of operations or those of our competitors; • changes in our earnings estimates or recommendations by securities analysts; • the payment of licensing fees or royalties in shares of our common stock; • announcements by us or our competitors of new prescription drug products or product candidates or non-prescription products, significant contracts, commercial relationships, acquisitions or capital commitments; • announcements relating to future development or license agreements including termination of such agreements; • adverse developments with respect to our intellectual property rights or those of our principal collaborators; • commencement of litigation involving us or our competitors; • any major changes in our board of directors or management; • new legislation in the US relating to the prescription, sale, distribution or pricing of gastrointestinal health products; • product liability claims, other litigation or public concern about the safety of our prescription drug product or product candidates and non-prescription products or any such future products; • market conditions in the human or animal industry, in general, or in the gastrointestinal health sector, in particular, including performance of our competitors; • future issuances of shares of common stock or other securities; 58 Table of Contents • general economic conditions in the US and abroad; and • market speculation regarding any of the foregoing.
These provisions include the following: • a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; • no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; 66 Table of Contents • the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; • the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could adversely affect the rights of our common stockholders or be used to deter a possible acquisition of our company; • the ability of our board of directors to alter our bylaws without obtaining stockholder approval; • the required approval of the holders of at least 75% of the shares entitled to vote at an election of directors to adopt, amend, or repeal our bylaws or repeal the provisions of our third amended and restated certificate of incorporation regarding the election and removal of directors; • a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; • the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president, or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and • advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
These provisions include the following: • a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; • no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; • the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; • the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could adversely affect the rights of our common stockholders or be used to deter a possible acquisition of our company; • the ability of our board of directors to alter our bylaws without obtaining stockholder approval; • the required approval of the holders of at least 75% of the shares entitled to vote at an election of directors to adopt, amend, or repeal our bylaws or repeal the provisions of our third amended and restated certificate of incorporation regarding the election and removal of directors; • a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; • the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president, or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and • advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
The successful development and commercialization of Mytesi, Canalevia-CA1 and Gelclair will depend on a number of factors, including the following: • our ability to demonstrate, to the satisfaction of the FDA and any other regulatory bodies, the safety and efficacy of Canalevia; • our ability and that of our contract manufacturers to manufacture supplies of Mytesi, Canalevia-CA1 and Gelclair, and to develop, validate, and maintain viable commercial manufacturing processes that are compliant with current good manufacturing practices, or cGMPs if required; • our ability to successfully market Mytesi, Canalevia-CA1 and Gelclair, whether alone or in collaboration with others; • the availability, perceived advantages, relative cost, relative safety, and relative efficacy of our prescription drug product candidates compared to alternative and competing treatments; • the acceptance of our prescription drug product candidates and non-prescription products as safe and effective by physicians, veterinarians, patients, animal owners, and the human and animal health community, as applicable; 42 Table of Contents • our ability to achieve and maintain compliance with all regulatory requirements applicable to our business; and • our ability to obtain and enforce our intellectual property rights and marketing exclusivity for our prescription drug product candidates and non-prescription products, and avoid or prevail in any third-party patent interference, patent infringement claims, or administrative patent proceedings initiated by third parties or the US Patent and Trademark Office (“USPTO”).
The successful development and commercialization of Mytesi, Canalevia-CA1 and Gelclair will depend on a number of factors, including the following: • our ability to demonstrate, to the satisfaction of the FDA and any other regulatory bodies, the safety and efficacy of Canalevia; • our ability and that of our contract manufacturers to manufacture supplies of Mytesi, Canalevia-CA1 and Gelclair, and to develop, validate, and maintain viable commercial manufacturing processes that are compliant with current good manufacturing practices, or cGMPs if required; • our ability to successfully market Mytesi, Canalevia-CA1 and Gelclair, whether alone or in collaboration with others; • the availability, perceived advantages, relative cost, relative safety, and relative efficacy of our prescription drug product candidates compared to alternative and competing treatments; • the acceptance of our prescription drug product candidates and non-prescription products as safe and effective by physicians, veterinarians, patients, animal owners, and the human and animal health community, as applicable; • our ability to achieve and maintain compliance with all regulatory requirements applicable to our business; and • our ability to obtain and enforce our intellectual property rights and marketing exclusivity for our prescription drug product candidates and non-prescription products, and avoid or prevail in any third-party patent interference, patent infringement claims, or administrative patent proceedings initiated by third parties or the US Patent and Trademark Office (“USPTO”).
Even if we successfully identify potential products, we may still fail to yield products for development and commercialization for many reasons, including the following: • competitors may develop alternatives that render our potential products obsolete; • an outside party may develop a cure for any disease state that is the target indication for any of our planned or approved drug products; • potential products we seek to develop may be covered by third-party patents or other exclusive rights; • a potential product may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; • a potential product may not be capable of being produced in commercial quantities at an acceptable cost or at all; and 43 Table of Contents • a potential product may not be accepted as safe and effective by physicians, veterinarians, patients, animal owners, key opinion leaders, and other decision-makers in the gastrointestinal health market, as applicable.
Even if we successfully identify potential products, we may still fail to yield products for development and commercialization for many reasons, including the following: • competitors may develop alternatives that render our potential products obsolete; • an outside party may develop a cure for any disease state that is the target indication for any of our planned or approved drug products; • potential products we seek to develop may be covered by third-party patents or other exclusive rights; • a potential product may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria; • a potential product may not be capable of being produced in commercial quantities at an acceptable cost or at all; and • a potential product may not be accepted as safe and effective by physicians, veterinarians, patients, animal owners, key opinion leaders, and other decision-makers in the gastrointestinal health market, as applicable.
The market for our human and animal products, and the gastrointestinal health market as a whole, is uncertain and may be smaller than we anticipate, which could lead to lower revenue and harm our operating results.
The market for our human and animal products, and the gastrointestinal health market as a whole, is uncertain and may be smaller than we anticipate, which could lead to lower product revenue and harm our operating results.
Our future capital requirements depend on many factors, including, but not limited to: • the scope, progress, results and costs of researching and developing our current and future prescription drug product candidates and non-prescription products; • the timing of, and the costs involved in, obtaining any regulatory approvals for our current and any future products; • the number and characteristics of the products we pursue; • the cost of manufacturing our current and future products and any products we successfully commercialize; • the cost of commercialization activities for Mytesi and Canalevia, if approved, including sales, marketing and distribution costs; • the expenses needed to attract and retain skilled personnel; • the costs associated with being a public company; • our ability to establish and maintain strategic collaborations, distribution, or other arrangements and the financial terms of such agreements; and • the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing possible patent claims, including litigation costs and the outcome of any such litigation.
Our future capital requirements depend on many factors, including, but not limited to: • the scope, progress, results and costs of researching and developing our current and future prescription drug product candidates and non-prescription products; • the timing of, and the costs involved in, obtaining any regulatory approvals for our current and any future products; • the number and characteristics of the products we pursue; • the cost of manufacturing our current and future products and any products we successfully commercialize; • the cost of commercialization activities for Mytesi and Canalevia, if approved, including sales, marketing and distribution costs; 33 Table of Contents • the expenses needed to attract and retain skilled personnel; • the costs associated with being a public company; • our ability to establish and maintain strategic collaborations, distribution, or other arrangements and the financial terms of such agreements; and • the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing possible patent claims, including litigation costs and the outcome of any such litigation.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our contract manufacturers or manufacturing processes, or failure to comply with regulatory requirements, are reportable events to the FDA and may result in, among other things: • restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, revised labeling, or voluntary or involuntary product recalls; • additional clinical studies, fines, warning letters or holds on target animal studies; • refusal by the FDA, or other regulators to approve pending applications or supplements to approved applications filed by us or our strategic collaborators related to the unknown problems, or suspension or revocation of the problematic product’s license approvals; • product seizure or detention, or refusal to permit the import or export of products; and • injunctions and/or the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with 52 Table of Contents our contract manufacturers or manufacturing processes, or failure to comply with regulatory requirements, are reportable events to the FDA and may result in, among other things: • restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, revised labeling, or voluntary or involuntary product recalls; • additional clinical studies, fines, warning letters or holds on target animal studies; • refusal by the FDA, or other regulators to approve pending applications or supplements to approved applications filed by us or our strategic collaborators related to the unknown problems, or suspension or revocation of the problematic product’s license approvals; • product seizure or detention, or refusal to permit the import or export of products; and • injunctions and/or the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with 62 Table of Contents our contract manufacturers or manufacturing processes, or failure to comply with regulatory requirements, are reportable events to the FDA and may result in, among other things: • restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, revised labeling, or voluntary or involuntary product recalls; • additional clinical studies fines, warning letters or holds on studies; • refusal by the FDA, or other regulators to approve pending applications or supplements to approved applications filed by Napo or Napo’s strategic collaborators related to the unknown problems or suspension or revocation of the problematic product’s license approvals; • product seizure or detention, or refusal to permit the import or export of products; and • injunctions or the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our contract manufacturers or manufacturing processes, or failure to comply with regulatory requirements, are reportable events to the FDA and may result in, among other things: • restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, revised labeling, or voluntary or involuntary product recalls; • additional clinical studies fines, warning letters or holds on studies; • refusal by the FDA, or other regulators to approve pending applications or supplements to approved applications filed by Napo or Napo’s strategic collaborators related to the unknown problems or suspension or revocation of the problematic product’s license approvals; • product seizure or detention, or refusal to permit the import or export of products; and • injunctions or the imposition of civil or criminal penalties.
As more fully discussed in Note 1 to our consolidated financial statements, we believe there is substantial doubt about our ability to continue as a going concern as we do not currently have sufficient cash resources to fund our operations through March 2026, or one year from the filing date of our Form 10-K.
As more fully discussed in Note 1 to our consolidated financial statements, we believe there is substantial doubt about our ability to continue as a going concern as we do not currently have sufficient cash resources to fund our operations through March 2027, or one year from the filing date of our Form 10-K.
As a result, we have limited meaningful historical operations upon which to evaluate our business and prospects and have not yet demonstrated an ability to broadly commercialize any of our human health products beyond Mytesi for HIV-related diarrhea or animal health products, obtain any required marketing approval for any of our animal prescription drug product candidates or successfully overcome the risks and uncertainties 39 Table of Contents frequently encountered by companies in emerging fields such as the animal health industry or the gastrointestinal health industry in general.
As a result, we have limited meaningful historical operations upon which to evaluate our business and prospects and have not yet demonstrated an ability to broadly commercialize any of our human health products beyond Mytesi for HIV-related diarrhea or animal health products, obtain any required marketing approval for any of our animal prescription drug product candidates or successfully overcome the risks and uncertainties frequently encountered by companies in emerging fields such as the animal health industry or the gastrointestinal health industry in general.
We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile and may decline. ITEM 1B.
We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile and may decline.
We may face challenges obtaining favorable reimbursement and insurance coverage for Gelclair, which could limit its market adoption and commercial success. Gelclair's commercial success significantly depends on obtaining favorable reimbursement and insurance coverage from third-party payers, including private insurance companies, Medicare, Medicaid, and other governmental programs.
We face challenges obtaining favorable reimbursement and insurance coverage for Gelclair, which limit its market adoption and commercial success. Gelclair's commercial success significantly depends on obtaining favorable reimbursement and insurance coverage from third-party payers, including private insurance companies, Medicare, Medicaid, and other governmental programs.
These expenditures will include costs associated with: • identifying additional potential prescription drug product candidates and non-prescription products; • formulation studies; • conducting pilot, pivotal, and toxicology studies; • completing other research and development activities; • payments to technology licensors; • maintaining our intellectual property; • obtaining necessary regulatory approvals; • establishing commercial supply capabilities; and • sales, marketing and distribution of our commercialized products.
These expenditures will include costs associated with: • identifying additional potential prescription drug product candidates and non-prescription products; • formulation studies; 32 Table of Contents • conducting pilot, pivotal, and toxicology studies; • completing other research and development activities; • payments to technology licensors; • maintaining our intellectual property; • obtaining necessary regulatory approvals; • establishing commercial supply capabilities; and • sales, marketing and distribution of our commercialized products.
The Company will have the opportunity to respond/present to the hearings panel as provided by Listing Rule 5815(d)(4)(C) and the Company’s securities may at that time be delisted from Nasdaq. On March 24, 2025, we effected a 1-for-25 reverse stock split of our outstanding voting common stock.
The Company will have the opportunity to respond/present to the hearings panel as provided by Listing Rule 5815(d)(4)(C) and the Company’s securities may at that time be delisted from Nasdaq. 56 Table of Contents On March 24, 2025, we effected a 1-for-25 reverse stock split of our outstanding voting common stock.
We will remain an SRC so long as (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $250 million or (b) (1) we have less than $100 million in annual revenues and (2) the 68 Table of Contents aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $700 million.
We will remain an SRC so long as (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $250 million or (b) (1) we have less than $100 million in annual revenues and (2) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter is less than $700 million.
We currently have sufficient quantities of the API used in Mytesi and Canalevia-CA1 to support our projected sales efforts. We are working with our contract manufacturers to increase the API manufacturing capacity of the API to support the sales forecast for 2025 and beyond.
We currently have sufficient quantities of the API used in Mytesi and Canalevia-CA1 to support our projected sales efforts. We are working with our contract manufacturers to increase the API manufacturing capacity of the API to support the sales forecast for 2026 and beyond.
Evolving expectations around corporate responsibility practices, specifically related to ESG matters, may expose us to reputational and other risks. Investors, stockholders, customers, suppliers, and other third parties are increasingly focusing on ESG and corporate social responsibility endeavors and reporting.
Evolving expectations around corporate responsibility practices, specifically related to Environmental, Social, and Governance ("ESG") matters, may expose us to reputational and other risks. Investors, stockholders, customers, suppliers, and other third parties are increasingly focusing on ESG and corporate social responsibility endeavors and reporting.
As previously announced, while the initial top line results from the OnTarget study showed that the clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types and all targeted therapies, in the prespecified subgroup of patients with breast cancer, crofelemer showed statistically significant improvement in the monthly responder analysis.
As previously announced, while the initial top line results from the OnTarget study showed that the clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types and all targeted therapies, in the 37 Table of Contents prespecified subgroup of patients with breast cancer, crofelemer showed statistically significant improvement in the monthly responder analysis.
Any significant adverse changes in the US political or economic climate may materially impact our business operations, financial condition, and future prospects. Fluctuations in the exchange rate of foreign currencies could result in currency transaction losses. As we expand our operations, we expect to be exposed to risks associated with foreign currency exchange rates.
Any significant adverse changes in the US political or economic climate may materially impact our business operations, financial condition, and future prospects. 44 Table of Contents Fluctuations in the exchange rate of foreign currencies could result in currency transaction losses. As we expand our operations, we expect to be exposed to risks associated with foreign currency exchange rates.
If one or more of these analysts ceases coverage of our company, we could lose visibility in the market, which in turn could cause the price of our common stock to decline. You may be diluted by exercises of outstanding options and warrants, and issuances of securities pursuant to our ATM Agreement and/or our stockholder rights plan.
If one or more of these analysts ceases coverage of our company, we could lose visibility in the market, which in turn could cause the price of our common stock to decline. You may be diluted by exercises of outstanding options and warrants, and issuances of securities pursuant to our ATM Agreement, our stockholder rights plan, or other equity arrangements.
In addition, factors that may cause a delay in the commencement or completion of our development efforts may also ultimately lead to the denial of regulatory approval of our product candidates, which, as described above, would harm our business and prospects. We will partially rely on third parties to conduct our development activities.
In addition, factors that may cause a delay in the commencement or completion of our development efforts may also ultimately lead to the denial of regulatory approval of our product candidates, which, as described above, would harm our business and prospects. 38 Table of Contents We will partially rely on third parties to conduct our development activities.
On December 21, 2021, the FDA conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of CID in dogs under application number 141-552. FDA’s conditional approval allows the Company to legally sell Canalevia-CA1 before proving it meets the “substantial evidence” standard of effectiveness for full approval.
On December 21, 2021, the FDA conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of CID in dogs under application number 141-552. FDA’s conditional approval allows the Company 42 Table of Contents to legally sell Canalevia-CA1 before proving it meets the “substantial evidence” standard of effectiveness for full approval.
If we are unable to prevent disclosure of our intellectual property to third parties, we may not be able to maintain a competitive advantage in our market, which would harm our business. 58 Table of Contents Any disclosure to or misappropriation of our confidential, proprietary information by third parties could enable competitors to quickly duplicate or surpass our technological achievements.
If we are unable to prevent disclosure of our intellectual property to third parties, we may not be able to maintain a competitive advantage in our market, which would harm our business. Any disclosure to or misappropriation of our confidential, proprietary information by third parties could enable competitors to quickly duplicate or surpass our technological achievements.
Finally, a new animal drug refers to drugs intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Our non-prescription Neonorm Foal and Neonorm Calf products are not intended to diagnose, cure, mitigate, treat, or prevent disease and, therefore, do not fit within the definition of an animal drug.
Finally, a new animal drug refers to drugs intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Our non-prescription Neonorm Foal and Neonorm Calf products are not intended to diagnose, cure, mitigate, treat, or 54 Table of Contents prevent disease and, therefore, do not fit within the definition of an animal drug.
The termination of either of these contracts would result in a disruption to product development and manufacturing, and harm our business. • We are dependent upon third-party contract manufacturers, both for the supply of the active pharmaceutical ingredients in Mytesi and Canalevia-CA1, as well as for the supply of finished products for commercialization.
The termination of either of these contracts would result in a disruption to product development and manufacturing, and harm our business. 30 Table of Contents • We are dependent upon third-party contract manufacturers, both for the supply of the active pharmaceutical ingredients in Mytesi and Canalevia-CA1, as well as for the supply of finished products for commercialization.
Because we anticipate incurring significant costs for the foreseeable future, if we are not successful in broadly commercializing any of our current or future products or product candidates or raising additional funding to 40 Table of Contents pursue our research and development efforts, we may never realize the benefit of our development efforts and our business may be harmed.
Because we anticipate incurring significant costs for the foreseeable future, if we are not successful in broadly commercializing any of our current or future products or product candidates or raising additional funding to pursue our research and development efforts, we may never realize the benefit of our development efforts and our business may be harmed.
Any failure by Mytesi, Canalevia, or our other products to achieve market acceptance or commercial success would harm our financial condition and the results of operations. Human and animal gastrointestinal health products are subject to unanticipated post-approval safety or efficacy concerns, which may harm our business and reputation.
Any failure by Mytesi, Canalevia, or our other products to achieve market acceptance or commercial success would harm our financial condition and the results of operations. 39 Table of Contents Human and animal gastrointestinal health products are subject to unanticipated post-approval safety or efficacy concerns, which may harm our business and reputation.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability, which would harm our business.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability, which would 55 Table of Contents harm our business.
If our contract manufacturer cannot manufacture sufficient quantities of the API in a timely manner, we could suffer losses due to lost sales opportunities. We currently have sufficient quantities of the botanical extract used in Neonorm and Equilevia to support planned 48 Table of Contents commercialization efforts for Neonorm and Equilevia.
If our contract manufacturer cannot manufacture sufficient quantities of the API in a timely manner, we could suffer losses due to lost sales opportunities. We currently have sufficient quantities of the botanical extract used in Neonorm and Equilevia to support planned commercialization efforts for Neonorm and Equilevia.
We may market or advertise Canalevia-CA1 and our animal health prescription drug product candidates approved by regulatory authorities only in the specific species and for treatment of the specific indications for which 49 Table of Contents they were approved, which could limit the use of the products by veterinarians and animal owners.
We may market or advertise Canalevia-CA1 and our animal health prescription drug product candidates approved by regulatory authorities only in the specific species and for treatment of the specific indications for which they were approved, which could limit the use of the products by veterinarians and animal owners.
On April 22, 1996, the FDA published a statement 61 Table of Contents in the Federal Register, 61 FR 17706, that it believes that the Dietary Supplement and Health Education Act (“DSHEA”) does not apply to animal health supplement products, such as our non-prescription products.
On April 22, 1996, the FDA published a statement in the Federal Register, 61 FR 17706, that it believes that the Dietary Supplement and Health Education Act (“DSHEA”) does not apply to animal health supplement products, such as our non-prescription products.
Accordingly, if our contract suppliers do not or are unable to comply with the terms of our respective agreements, and we are not able to negotiate new agreements with alternate suppliers on terms that we deem commercially reasonable, it may harm our business and prospects.
Accordingly, if our contract suppliers do not or are unable to comply with the terms of 40 Table of Contents our respective agreements, and we are not able to negotiate new agreements with alternate suppliers on terms that we deem commercially reasonable, it may harm our business and prospects.
We currently intend to invest our future earnings, if any, to fund our growth and not to pay any cash dividends on our common stock. Because we do not intend to pay dividends, your ability to receive a return on your investment will depend on any future appreciation in the market price of our common stock.
We do not intend to pay dividends on our common stock, and your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock. We currently intend to invest our future earnings, if any, to fund our growth and not to pay any cash dividends on our common stock.
Our business, financial condition, results of operations, or prospects could be adversely affected by general conditions in the global economy and in the global financial markets.
Our business, financial condition, results of operations, cash flows or prospects could be adversely affected by general conditions in the global economy and in the global financial markets.
Any failure or delay in the development of our internal sales, marketing, and distribution capabilities and entry into adequate arrangements with distributors or other partners would adversely impact the commercialization of Mytesi, Canalevia-CA1, Gelclair, and/or any of our other products.
Any failure or delay in the development of our internal 41 Table of Contents sales, marketing, and distribution capabilities and entry into adequate arrangements with distributors or other partners would adversely impact the commercialization of Mytesi, Canalevia-CA1, Gelclair, and/or any of our other products.
Our compliance with applicable provisions of Section 404 requires that we incur substantial accounting expenses and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements.
Our compliance with applicable provisions of 61 Table of Contents Section 404 requires that we incur substantial accounting expenses and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements.
If slower growth in the global economy or in any of the markets we serve continues for a significant period, if there is significant deterioration in the global economy or such markets, or if improvements in the global economy don’t benefit the markets we serve, our business and financial statements could be adversely affected.
If slower growth in the global economy or in any of the markets we serve continues for a significant period, if there is significant deterioration in the global economy or such markets, or if improvements in the global economy don’t benefit the markets we serve, our business could be adversely affected.
For these reasons, we cannot be certain that we and Mytesi can compete effectively. We may be unable to obtain, or obtain on a timely basis, regulatory approval for our existing or future human or animal prescription drug product candidates under applicable regulatory requirements, which would harm our operating results.
For these reasons, we cannot be certain that we and Mytesi can compete effectively. 36 Table of Contents We may be unable to obtain, or obtain on a timely basis, regulatory approval for our existing or future human or animal prescription drug product candidates under applicable regulatory requirements, which would harm our operating results.
We may not maintain the benefits associated with MUMS designation, including market exclusivity. Although we have received MUMS designation for Canalevia-CA1 for the treatment of CID in dogs, we may not maintain the benefits associated with MUMS designation. MUMS designation is a status similar to “orphan drug” status for human drugs.
Although we have received MUMS designation for Canalevia-CA1 for the treatment of CID in dogs, we may not maintain the benefits associated with MUMS designation. MUMS designation is a status similar to “orphan drug” status for human drugs.
A severe or prolonged economic downturn, 54 Table of Contents including as a result of the ongoing war in Ukraine, interest rate fluctuations, rising inflation, recession, or other global financial or geopolitical crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.
A severe or prolonged economic downturn, including as a result of the ongoing war in Ukraine and Iran, interest rate fluctuations, rising inflation, recession, or other global financial or geopolitical crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.
Insurance coverage for Mytesi for its current approved indication could decrease or end, or Mytesi might not receive insurance coverage for any approved follow-on indications, which could lead to lower revenue and harm our operating results. For its current approved indication, Mytesi is currently reimbursed by almost all of commercial and Medicare insurance plans.
Insurance coverage for Mytesi for its current approved indication could continue to be limited or end, or Mytesi might not receive insurance coverage for any approved follow-on indications, which could lead to lower revenue and harm our operating results. For its current approved indication, Mytesi is currently reimbursed by almost all of commercial and Medicare insurance plans.
We cannot be 55 Table of Contents certain that pending applications will be issued as patents. For those patents that are already issued and even if other patents are successfully issued, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, invalidated, or held unenforceable.
We cannot be certain that pending applications will be issued as patents. For those patents that are already issued and even if other patents are successfully issued, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, invalidated, or held unenforceable.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the US.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export 51 Table of Contents otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the US.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedurals, documentary, fee payment, and other similar provisions during the patent application process.
The 48 Table of Contents USPTO and various foreign governmental patent agencies require compliance with a number of procedurals, documentary, fee payment, and other similar provisions during the patent application process.
Even though Gelclair is FDA-approved and has demonstrated clinical benefits, insurers may limit reimbursement or require higher patient co-payments or other restrictions, potentially making Gelclair less 51 Table of Contents accessible to patients.
Even though Gelclair is FDA-approved and has demonstrated clinical benefits, insurers may limit reimbursement or require higher patient co-payments or other restrictions, potentially making Gelclair less accessible to patients.
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution or other basis for a finding of invalidity. Litigation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.
Such a loss of patent protection could harm our business. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution or other basis for a finding of invalidity. Litigation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.
Therefore, even if 44 Table of Contents our studies and other development activities are completed as planned, the results may not be sufficient to obtain the required regulatory approval for a product candidate.
Therefore, even if our studies and other development activities are completed as planned, the results may not be sufficient to obtain the required regulatory approval for a product candidate.
Additionally, cyber-attacks could also compromise trade secrets and other sensitive information and result in such information being disclosed to others and becoming less valuable, which could 53 Table of Contents negatively affect our business.
Additionally, cyber-attacks could also compromise trade secrets and other sensitive information and result in such information being disclosed to others and becoming less valuable, which could negatively affect our business.
The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information.
The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document 57 Table of Contents containing specified information.
The exercise of such options, warrants, and vesting of RSUs will result in further dilution of your investment. In addition, you may experience further dilution if we issue common stock in the future, including common stock issued pursuant to our existing At The Market Offering Agreement dated December 10, 2021, by and between the Company and Ladenburg Thalmann & Co.
The exercise of such options, warrants, and vesting of RSUs will result in further dilution of your investment. 59 Table of Contents In addition, you may experience further dilution if we issue common stock in the future, including common stock from other equity arrangements or issued pursuant to our existing At The Market Offering Agreement dated December 10, 2021, by and between the Company and Ladenburg Thalmann & Co.
Risks Related to Our Business • We have a limited operating history, expect to incur further losses as we grow, and may be unable to achieve or sustain profitability. • We expect to incur significant additional costs as we continue commercialization efforts for current prescription drug candidates or other product candidates and undertake the clinical trials necessary to obtain any necessary regulatory approvals, which will increase our losses. • We will need to raise substantial additional capital in the future in the event that we conduct clinical trials for new indications and for the launch of Gelclair, and we may be unable to raise such funds when needed and on acceptable terms, which would force us to delay, limit, reduce or terminate one or more of our product development programs. • We are substantially dependent on the success of Mytesi, our current lead prescription drug product, and Canalevia-CA1, our conditionally approved prescription drug product for CID in dogs.
Risks Related to Our Business • We have a limited operating history, expect to incur further losses as we grow, and may be unable to achieve or sustain profitability. • We expect to incur significant additional costs as we continue research and development efforts for current prescription drug candidates or other product candidates and undertake the clinical trials necessary to obtain any necessary regulatory approvals, as we focus on rare disease programs. • We will need to raise substantial additional capital in the future in the event that we conduct clinical trials for new indications and for new products, and we may be unable to raise such funds when needed and on acceptable terms, which would force us to delay, limit, reduce or terminate one or more of our product development programs. • We are substantially dependent on the success of our new licensee, Woodward Specialty LLC (“Woodward”) and its affiliates, for Mytesi, our current lead prescription drug product, and Canalevia-CA1, our conditionally approved prescription drug product for CID in dogs.
The FCPA prohibits US corporations and their representatives from offering, promising, authorizing, or making payments to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business abroad. The scope of the FCPA includes interactions with certain healthcare professionals in many countries.
The FCPA prohibits US corporations and their representatives from offering, promising, authorizing, or making payments to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business abroad. The scope of the FCPA includes interactions with certain healthcare professionals in many countries. Other countries have enacted similar anti-corruption laws and/or regulations.
We expect to incur significant additional costs as we continue commercialization efforts for current prescription drug candidates or other product candidates and undertake the clinical trials necessary to obtain any necessary regulatory approvals, which will increase our losses. Napo commenced sales of Mytesi for adults with HIV/AIDS on antiretroviral therapy in September 2016.
We expect to incur significant additional costs as we continue commercialization efforts for current prescription drug candidates or other product candidates and undertake the clinical trials necessary to obtain any necessary regulatory approvals, as we focus on rare disease programs. Napo commenced sales of Mytesi for adults with HIV/AIDS on antiretroviral therapy in September 2016.
Our obligations under the secured promissory note issued to Streeterville Capital, LLC (“Streeterville”) are secured by a first priority security interest in all existing and future NP-300 technology held by Napo, including intellectual property, as provided in the Security Agreement, dated January 19, 2021, between Napo and Streeterville.
Our obligations under the secured promissory notes issued to Streeterville are secured by a first priority security interest in all existing and future NP-300 technology held by Napo, including intellectual property, as provided in the Security Agreement, dated January 19, 2021, between Napo and Streeterville and the Security Agreement, dated March 6, 2026, between Napo and Streeterville.
Other countries have enacted similar anti-corruption laws and/or regulations. 52 Table of Contents Our international operations subject us to these laws and regulations, which are complex, restrict our business dealings with certain countries, governments, entities, and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced, or interpreted in a manner that materially impacts our operations.
Our international operations subject us to these laws and regulations, which are complex, restrict our business dealings with certain countries, governments, entities, and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced, or interpreted in a manner that materially impacts our operations.
We have experienced and may continue to experience significant volatility in the price of our common stock. From January 2, 2024, through January 30, 2025, the share price of our common stock ranged from a high of $540 to a low of $19.5. The reason for the volatility in our stock is not well understood and may continue.
We have experienced and may continue to experience significant volatility in the price of our common stock. From January 2, 2025, through January 30, 2026, the share price of our common stock ranged from a high of $32 to a low of $0.67. The reason for the volatility in our stock is not well understood and may continue.
These royalty interests require us to make minimum royalty payments beginning in 2021, even if we do not sell a sufficient amount of product to cover such payments, which may strain our cash resources. The total minimum royalty payments will be approximately $27.0 million in 2026.
These royalty interests (as amended) require us to make minimum royalty payments beginning from July 2026, even if we do not sell a sufficient amount of product to cover such payments, which may strain our cash resources. Total minimum royalty payments, approximately totaling $27.0 million, will commence in 2026.
During the year ended December 31, 2024, we sold 388,634 shares of common stock pursuant to the terms of the ATM Agreement for net proceeds of $30.8 million. As a result of this dilution, you may receive significantly less in net tangible book value than the full purchase price you paid for the shares in the event of liquidation.
During the year ended December 31, 2025, we sold 2,159,049 shares of common stock pursuant to the terms of the ATM Agreement for net proceeds of $6.3 million. As a result of this dilution, you may receive significantly less in net tangible book value than the full purchase price you paid for the shares in the event of liquidation.
General economic conditions, both inside and outside the US, including heightened inflation, capital market volatility, interest rate and currency rate fluctuations, economic slowdown or recession, and geopolitical events, including civil or political unrest (such as the ongoing war between Ukraine and Russia), have resulted in a significant disruption of global financial markets.
General economic conditions, both inside and outside the US, including heightened inflation, capital market volatility, interest rate and currency rate fluctuations, economic slowdown or recession, and geopolitical events, including civil or political unrest (e.g. Ukraine Conflict and Iran Conflict), have resulted in a significant disruption of global financial markets.
A weak or declining economy could also strain our suppliers and contract manufacturing organizations (“CMO”), possibly resulting in supply or manufacturing disruption. Any of the foregoing could harm our business and we cannot anticipate all the ways in which such conditions could adversely impact our business. Substantially all of our revenue for recent periods has been received from two customers.
A weak or declining economy could also strain our suppliers and contract manufacturing organizations (“CMO”), possibly resulting in supply or manufacturing disruption. Any of the foregoing could harm our business and we cannot anticipate all the ways in which such conditions could adversely impact our business.
This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in shares of our common stock that are not directly correlated to our company's performance or prospects.
This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in shares of our common stock that are not directly correlated to our company's performance or prospects. Once investors purchase the shares necessary to cover their short position, the price of our common stock may decline.
The composition-of-matter patents for crofelemer, the API in Mytesi and Canalevia-CA1 have expired, and the issued patents and applications relevant to our products and product candidates cover methods of use for crofelemer and the botanical extract in Neonorm and Equilevia.
The composition-of-matter patents for crofelemer, the API in Mytesi and Canalevia-CA1 have expired, and the issued patents and applications relevant to our products and product candidates cover methods of use for crofelemer and the botanical extract in Neonorm and Equilevia. 49 Table of Contents Method-of-use patents protect the use of a product for the specified method, and formulation patents cover formulations of the API or botanical extract.
If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on one or more of our products or our current or future product candidates. Such a loss of patent protection could harm our business.
The outcome following legal assertions of invalidity and unenforceability is unpredictable. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on one or more of our products or our current or future product candidates.
Indena is a producer of the API used to manufacture Canalevia-CA1 and Mytesi, as well as the botanical extract in Neonorm. Glenmark is the current manufacturer of crofelemer, the active API in Canalevia-CA1 and Mytesi.
Indena is a producer of Crofelemer and the botanical extract in Neonorm. Alivus used to be the manufacturer of crofelemer, the active API in Canalevia-CA1 and Mytesi.
Our revenues to date have been insufficient to offset our expenses, and we expect to continue to incur significant research and development and other expenses. Our net comprehensive losses for the years ended December 31, 2024 and 2023, were $39.0 million and $41.9 million, respectively. As of December 31, 2024, we had a total stockholder equity of $6.5 million.
Our revenues to date have been insufficient to offset our expenses, and we expect to continue to incur significant research and development and other expenses. Our net comprehensive losses for the years ended December 31, 2025 and 2024, were $54.4 million and $39.0 million, respectively. As of December 31, 2025, we had a total stockholder's deficit of $18.7 million.
If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. 59 Table of Contents We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.
Further, even if we are successful in the ongoing commercialization of Mytesi, Canalevia-CA1 and our other product candidates, we may not achieve commercial success. If we obtain necessary regulatory approvals for planned follow-on indications of crofelemer or our other product candidates, such products may still not achieve market acceptance and may not be commercially successful.
Even if we obtain regulatory approval for planned follow-on indications of crofelemer, Canalevia, or our other product candidates, they may never achieve market acceptance. Further, even if Woodward is successful in the ongoing commercialization of Mytesi, Canalevia-CA1 and our other product candidates, we may not achieve commercial success.
The listing of our common stock on The Nasdaq Capital Market does not assure that a meaningful, consistent, and liquid trading market exists. Although our common stock is listed on The Nasdaq Capital Market, its trading volume has been limited, and an active trading market for our shares may never develop or be sustained.
Although our common stock is listed on The Nasdaq Capital Market, its trading volume has been limited, and an active trading market for our shares may never develop or be sustained.
Jaguar launched Canalevia-CA1 for chemotherapy-induced diarrhea (“CID”) in dogs in December 2021. We will need to continue to invest in developing our internal and third-party sales and distribution network and outreach efforts to key opinion leaders in the gastrointestinal health industry, including physicians and veterinarians, as applicable.
We will need to continue to invest in developing our internal and third-party sales and distribution network and outreach efforts to key opinion leaders in the gastrointestinal health industry, including physicians and veterinarians, as applicable.
In addition, third parties may obtain patents in the future and claim that the use of our technologies infringes upon these patents. 56 Table of Contents To the extent we become subject to future third-party claims against us or our collaborators, we could incur substantial expenses, and if any such claims are successful, we could be liable to pay substantial damages, including treble damages and attorney’s fees if we or our collaborators are found to be willfully infringing a third-party’s patents.
To the extent we become subject to future third-party claims against us or our collaborators, we could incur substantial expenses, and if any such claims are successful, we could be liable to pay substantial damages, including treble damages and attorney’s fees if we or our collaborators are found to be willfully infringing a third-party’s patents.
The conditional approval automatically terminates five years after the date of the initial conditional 50 Table of Contents approval. If FDA does not fully approve the drug before the five-year termination date, the Company would then have to stop marketing the drug because it would be considered to be unapproved.
The conditional approval automatically terminates five years after the date of the initial conditional approval. If FDA does not fully approve the drug before the five-year termination date, the Company would then have to stop marketing the drug because it would be considered to be unapproved. We may not maintain the benefits associated with MUMS designation, including market exclusivity.
If the market potential for our human or animal products is less than we anticipate due to one or more of these factors, it could negatively impact our business, financial condition and results of operations. Further, the willingness of patients to pay for our products may be less than we anticipate, and may be negatively affected by overall economic conditions.
If the market potential for our human or animal products is less than we anticipate due to one or more of these factors, it could negatively impact our business, financial condition and 43 Table of Contents results of operations.
There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter. If our shares become subject to the penny stock rules, it would become more difficult to trade our shares.
There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter.
As a result, if we default on our obligations under these agreements, Streeterville could foreclose on its security interests and liquidate some or all of these assets, which would harm our plans to develop and commercialize NP-300, financial condition and results of operations and could require us to reduce or cease operations with respect to NP-300.
As a result, if we default on our obligations under these agreements, Streeterville could foreclose on its security interests and liquidate some or all of these assets, which would harm our plans to develop and commercialize NP-300, financial condition and results of operations and could require us to reduce or cease operations with respect to NP-300. 45 Table of Contents Our royalty interests require us to make minimum royalty payments, even if we do not sell a sufficient amount of products to cover such payments, which may strain our cash resources.
Alternatively, if a court were to find this provision of our amended and restated bylaws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could harm our business and financial condition. 67 Table of Contents We do not intend to pay dividends on our common stock, and your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.
Alternatively, if a court were to find this provision of our amended and restated bylaws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could harm our business and financial condition.
Because line extensions are developed for a particular market, we may not be able to leverage our experience from the commercial launch of Mytesi in new markets.
Because line extensions are developed for a particular market, we may not be able to leverage our experience from the commercial launch of Mytesi in new markets. If we are not successful in developing and successfully commercializing these line extension products, we may not be able to grow our revenue, and our business may be harmed.
Further, this increased focus on ESG issues may result in new regulations and/or third-party requirements that could adversely impact our business or certain stockholders reducing or eliminating their holdings of our stock. Additionally, an allegation or perception that we have not taken sufficient action in these areas could negatively harm our reputation.
Further, this increased focus on ESG issues may result in new regulations and/or third-party requirements that could adversely impact our business or certain stockholders reducing or eliminating their holdings of our stock.
We will need to seek additional funds through public or private equity or debt financing or other sources such as strategic collaborations. Any such financings or collaborations may result in dilution to our stockholders, the imposition of debt covenants and repayment obligations, or other restrictions that may harm our business or the value of our common stock.
Any such financings or collaborations may result in dilution to our stockholders, the imposition of debt covenants and repayment obligations, or other restrictions that may harm our business or the value of our common stock.
Current economic conditions may adversely affect the ability of our distributors, customers, suppliers, and service providers to obtain the liquidity required to pay for our products or to buy necessary inventory or raw materials and to perform their obligations under agreements with us, which could disrupt our operations, and could negatively impact our business and cash flow.
A reduction in the availability or extent of reimbursement from government and/or private payer healthcare programs could have a material adverse effect on the sales of our products, our business, the results of our operations and cash flows. 46 Table of Contents Current economic conditions may adversely affect the ability of our distributors, customers, suppliers, and service providers to obtain the liquidity required to pay for our products or to buy necessary inventory or raw materials and to perform their obligations under agreements with us, which could disrupt our operations, and could negatively impact our business and cash flow.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur board of directors administers its cybersecurity risk oversight function directly as a whole, as well as through the audit committee.
Biggest changeOur board of directors administers its cybersecurity risk oversight function directly as a whole, as well as through the audit committee. Our Chief Financial Officer and Chief Compliance Officer are primarily responsible for assessing and managing our material risks from cybersecurity threats with assistance from third-party service providers.
Our Chief Compliance Officer and IT consultant provide periodic briefings to the audit committee regarding our company’s cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, cybersecurity systems testing, activities of third parties, and the like. Our audit committee provides regular updates to the board of directors on such reports. ITEM 2.
Our Chief Compliance Officer and IT consultant provide periodic briefings to the audit committee regarding our company’s cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, cybersecurity systems testing, activities of third parties, and the like. Our audit committee provides regular updates to the board of directors on such reports. 66 Table of Contents ITEM 2.
The cybersecurity risk management program includes tools and activities to prevent, detect, and analyze current and emerging cybersecurity threats and plans and strategies to address threats and incidents.
Our Chief Financial Officer and Chief Compliance Officer oversee our cybersecurity policies and processes, including those described in “Risk Management and Strategy” above. The cybersecurity risk management program includes tools and activities to prevent, detect, and analyze current and emerging cybersecurity threats and plans and strategies to address threats and incidents.
Removed
Our Chief Financial Officer and Chief Compliance Officer are primarily responsible for assessing and managing our material risks from cybersecurity threats with assistance from third-party service providers. 69 Table of Contents Our Chief Financial Officer and Chief Compliance Officer oversee our cybersecurity policies and processes, including those described in “Risk Management and Strategy” above.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeWe are not currently subject to any material legal proceedings. ITEM 4. MI NE SAFETY DISCLOSURE Not applicable. 70 Table of Contents P ART II
Biggest changeWe are not currently subject to any material legal proceedings. ITEM 4. MI NE SAFETY DISCLOSURE Not applicable. 67 Table of Contents P ART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosure 70 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 71 Item 6. Selected Financial Data 72 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 73 Item 7A. Qualitative and Quantitative Disclosures About Market Risk 87 Item 8.
Biggest changeItem 4. Mine Safety Disclosure 67 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 68 Item 6. Selected Financial Data 71 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 72 Item 7A. Qualitative and Quantitative Disclosures About Market Risk 90 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities On January 29, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville pursuant to which the Company issued 1,058 shares of the Company’s common stock, par value $0.0001 to Streeterville in exchange for a $165,000 reduction in the outstanding balance of the royalty interest dated August 24, 2022.
Biggest changeOn June 27, 2025, the Company entered into a privately negotiated exchange agreements (the “Iliad Series M Exchange Agreement” and the “Streeterville Series M Exchange Agreement”) with Iliad and Streeterville, pursuant to which Company issued 170 shares and 90 shares of Series M Preferred Stock to Iliad and Streeterville, respectively, in exchange for a $4,250,000 reduction in the outstanding balance of the October 2020 Purchase Agreement and a $2,250,000 reduction in the outstanding balance of the August 2022 Royalty Interest, respectively.
ITEM 5. MARKET FOR REGISTRANT’S CO MMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock trades on The Nasdaq Capital Market under the symbol “JAGX.” Holders As of March 31, 2025, there were approximately seventeen stockholders of record of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S CO MMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock trades on The Nasdaq Capital Market under the symbol “JAGX.” Holders As of April 7, 2026, there were approximately nine stockholders of record of our common stock.
Subsequent Events for subsequent sales of unregistered securities.
Refer to Item 16. Subsequent Events for subsequent sales of unregistered securities.
On January 29, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of 5,333 shares of the Company’s common stock to Iliad in exchange for a $836,000 reduction in the outstanding balance of the royalty interest dated October 8, 2020, Royalty Interest.
On May 13, 2025, the Company entered into a privately negotiated exchange agreement with Iliad, pursuant to which the Company issued an aggregate of 60,000 shares of common stock to Iliad in exchange for a $466,200 reduction in the outstanding balance of the October 2020 Purchase Agreement.
On March 1, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of 179 shares of Series J Preferred Stock to Streeterville in exchange for the surrender of the March 2021 Royalty Interest by Streeterville.
On November 17, 2025, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of 361,271 shares of common stock to Streeterville in exchange for 25 outstanding shares of Series M Preferred Stock held by Streeterville.
Other than equity securities issued in transactions disclosed above and on our Current Report on Form 8-K filed with the SEC on March 1, 2024, March 8, 2024, March 21, 2024, June 10, 2024, and July 16, 2024, there were no unregistered sales of equity securities during the period. Refer to Item 15.
Other than equity securities issued in transactions disclosed above and on our Current Report on Form 8-K filed with the SEC on February 4, 2025 and March 26, 2025, May 2, 2025, May 15, 2025, May 22, 2025, June 24, 2025, June 30, 2025, September 11, 2025, October 1, 2025, October 3, 2025, November 19, 2025, and December 12, 2025, and on Form 8-K/A on April 25, 2025, there were no unregistered sales of equity securities during the period.
On July 15, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of 18,200 shares of the Company's common stock to Iliad in exchange for a $1.9 million reduction in the outstanding balance of the original royalty interest.
On April 30, 2025, the Company entered into a privately negotiated exchange agreement with Iliad Research and Trading, L.P. (“Iliad”) pursuant to which the Company issued an aggregate of 57,500 shares of common stock to Iliad in exchange for $632,500 reduction in the outstanding balance of October 2020 Purchase Agreement.
On March 5, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued 6,667 shares of the Company’s common stock in exchange for the surrender and cancellation of 40 shares of Series J Perpetual Preferred Stock.
On May 14, 2025, the Company entered into privately negotiated exchange agreements with Iliad and Streeterville, under which the Company issued 22 and 99.3822 shares of Series L Preferred Stock to Iliad and Streeterville, respectively, in exchange for a $550,000 reduction in the outstanding balance of the October 2020 Purchase Agreement, and for all of the outstanding 99.3822 shares of Series J Preferred Stock held by Streeterville, respectively.
The effect of the exchange was accounted for as a debt modification. On July 18, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of 8,000 shares of the Company's common stock to Iliad in exchange for $819,000 reduction in the outstanding balance of the original royalty interest.
Pursuant to such exchange agreement, the Company issued 51,600 shares of common stock to such holder in exchange for a $1,094,952 reduction in the outstanding balance of the royalty interest held by Uptown.
On March 19, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued 5,556 shares of the Company’s common stock in exchange for the surrender and cancellation of 40 shares of Series J Perpetual Preferred Stock based on an effective exchange price of $180.00 per share of common stock.
On December 9, 2025, the Company entered into a privately negotiated exchange agreement with Iliad (the “First Exchange Agreement”), pursuant to which the Company issued (i) 400,000 shares (the “First Exchange Shares”) of common stock and (ii) a pre-funded common stock purchase warrant to purchase 1,304,545 shares of common stock (the “First Pre-Funded Warrant”) to Iliad in exchange for 75 shares of Series M Preferred Stock held by Iliad (the “First Exchange Transaction”).
Removed
The effect of the exchange was accounted for as a debt modification. On February 27, 2024, pursuant to the PIPE Purchase Agreement, each of the PIPE investors entered into an exchange agreement with the Company (each, a “PIPE Warrant Exchange Agreement” and collectively, the “PIPE Warrant Exchange Agreements”).
Added
Recent Sales of Unregistered Securities On January 28, 2025, the Company entered into a privately negotiated exchange agreement with Uptown Capital, LLC (f/k/a Irving Park Capital, LLC) (“Uptown”).
Removed
Pursuant to the PIPE Warrant Exchange Agreements, the Company agreed to exchange the PIPE Warrants for shares of common stock at an exchange ratio of 1-for-2.5 (“PIPE Warrant Exchange Transaction”).
Added
The shares of common stock that were issued in this exchange transaction were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act of 1933, as amended (“Securities Act”).
Removed
Upon completion of the PIPE Warrant Exchange Transaction, the Company exchanged the PIPE Warrants to purchase up to 5,023 shares of Common Stock for 12,558 shares of Common Stock (the “PIPE Exchange Shares”), and the PIPE Warrants were terminated.
Added
On March 26, 2025, the Company entered into securities purchase agreements (the “Convertible Note Purchase Agreements”) with selected institutional and accredited investors (each, a “Note Investor”), pursuant to which the Company agreed to issue approximately $3.4 million aggregate principal amount of convertible promissory notes (collectively, the “Notes”) and warrants to purchase up to 622,584 shares of common stock to the Note Investors (the “Convertible Notes Financing”).
Removed
The PIPE Exchange Shares would be subject to a twelve-month lock-up, and any other equity security of the Company other than the PIPE Exchange Shares owned by the PIPE investors as of the date of the PIPE Warrant Exchange Agreement would be subject to a six-month lock-up.
Added
The Convertible Notes Financing closed on March 31, 2025. The Notes bore interest at the rate of 6% per annum and would mature on June 30, 2025 (the “Maturity Date”).
Removed
Upon completion of the CVP Exchange Transaction, all outstanding balance of the March 2021 Royalty Interest was fully paid, and the March 2021 Royalty Interest was terminated.
Added
The Notes were convertible, at each holder’s option, in part or in full, into an aggregate of 622,598 shares (the “Conversion Shares”) of common stock, at a conversion price of $5.535 per share for Investors who were not an officer, director, employee or consultant of the Company (collectively, an “Insider”), and $5.555 per share for Investors who were Insiders, subject to adjustment for customary stock dividend, stock split, stock combination or other similar transactions.
Removed
On March 18, 2024, the Company entered into a privately negotiated securities purchase agreement with Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S., ("Gen") pursuant to which the Company issued 11,111 shares of the Company’s common stock at $3.00 per share for gross proceeds of approximately $2.0 million.
Added
As an inducement to enter into the Convertible Note Purchase Agreements, the Investors received warrants (collectively, the “Convert Warrants”) to purchase up to an aggregate of 622,598 shares of common stock (the “Convert Warrant Shares”) with a fair value of $3.3 million and an initial exercise price equal to $5.41 per share for Investors who were not Insiders, and $5.43 per share for Investors who were Insiders, in each case subject to adjustment for reclassification of the common stock, non-cash dividend, stock split, reverse stock split or other similar transaction (the “Convert Warrant Exercise Price”).
Removed
The sale of the 71 Table of Contents securities was consummated in connection with the licensing transaction covering the exclusive license and commercialization agreement for the Company's FDA-approved prescription drug Crofelemer with purchasers in certain Eastern European countries.
Added
The Convert Warrants would be exercisable immediately upon issuance and would expire on the earlier of (i) March 31, 2030, (ii) the consummation of a fundamental transaction and (iii) the consummation of a liquidation event (the “Convert Warrant Expiration Date”).
Removed
On June 7, 2024, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $1,500,000 from the outstanding balance of the royalty interest dated October 8, 2020. This reduced the outstanding balance of the original royalty interest. The partitioned royalty was exchanged for 262 shares of the Company’s common stock.
Added
Certain Insiders, including the Company’s Chief Executive Officer, Chief Financial Officer and certain members of the Company’s board of directors and officers, participated in the Private Placement.
Removed
The effect of the exchange was accounted for as a debt modification.
Added
These Insiders purchased $535,000 aggregate principal amount of the Notes, which were convertible into up to 96,309 Conversion Shares, and received Convert Warrants to purchase up to 96,309 Convert Warrant Shares. 68 Table of Contents In connection with the Convertible Notes Financing, the Company issued to H.C.
Added
Wainwright & Co., LLC (“Wainwright”), the placement agent for the Convertible Notes Financing, warrants to purchase up to 37,376 shares of common stock (the “Convert PA Warrants”) with a fair value of $259,000. The Convert PA Warrants are immediately exercisable, would expire on the Convert Warrant Expiration Date, and have an exercise price of $6.9188 per share.
Added
The shares of common stock that were issued in this exchange transaction were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
The shares of common stock were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
The shares of Series L Preferred Stock were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
On May 20, 2025, the Company entered into a securities purchase agreement with selected institutional investors for a registered direct offering (the “Registered Offering”) of 246,306 shares of common stock at $6.09 per share, priced at-the-market under Nasdaq rules.
Added
In a concurrent private placement, the Company issued to such investors unregistered warrants to purchase up to 492,612 shares of common stock (“Common Warrants”) at an exercise price of $5.84 per share. The Common Warrants are immediately exercisable and expire upon the earlier of (i) 24 months from issuance, (ii) a fundamental transaction, or (iii) a liquidation event.
Added
The Company also issued to Wainwright warrants to purchase 14,778 shares of common stock (the “Wainwright Warrants”), representing 6.0% of the shares sold in the Registered Offering.
Added
The Wainwright Warrants have substantially similar terms to the Common Warrants issued to investors in the same transaction, but with an exercise price of $7.6125 per share, which represents 125% of the offering price.
Added
On June 24, 2025, the Company completed a private exchange transaction with selected accredited investors (the “Participating Investors”), issuing approximately $2.57 million aggregate principal amount of new 6% convertible promissory notes (the “Replacement Notes”) in exchange for the cancellation of the March 2025 Convertible Notes held by such Participating Investors (the “Note Exchange Transaction”).
Added
The Replacement Notes would mature on January 30, 2026, bore interest at 6% per annum, and were immediately convertible at the option of the holders into up to 481,150 shares of the Company’s common stock at a conversion price of $5.535 per share for non-Insiders and $5.555 per share for Insiders, subject to adjustment for customary stock dividend, stock split, stock combination or other similar transactions; provided, however, that (a) no conversion shares may be issued to a noteholder who was an Insider unless the stockholder approval was obtained by the Company in accordance with Nasdaq Listing Rules 5635(c) and 5635(d), and (b) the total cumulative number of conversion shares that may be issued to a noteholder who was not an Insider, together with any shares of Common Stock issued to (i) such noteholder upon exercise of the New Warrants issued to such noteholder and (ii) the other Participating Investors in the same series of transactions as the Replacement Notes, may not exceed the requirements of The Nasdaq Capital Market (including the rules related to the aggregation of offerings under Nasdaq Listing Rule 5635(d), if applicable) (the “Issuance Cap”), unless the stockholder approval was obtained by the Company to issue more than the Issuance Cap.
Added
The Company also issued warrants to purchase common stock (the “New Warrants”) and agreed to file a registration statement for the resale of the related conversion shares and warrant shares.
Added
In connection with the Note Exchange Transaction, the Company issued to the Participating Investors New Warrants to purchase up to an aggregate of 928,582 shares of common stock (the “New Warrant Shares”) with an initial exercise price equal to $2.70, subject to adjustment for reclassification of the common stock, non-cash dividend, stock split, reverse stock split or other similar transaction.
Added
The New Warrants would be exercisable 69 Table of Contents immediately upon the Initial Exercise Date (as define therein) and would expire on the earlier of (i) 18 months from the date of issuance, (ii) the consummation of a fundamental transaction and (iii) the consummation of a liquidation event; provided, however, that no New Warrant Shares may be issued to a holder unless the stockholder approval was obtained by the Company in accordance with Nasdaq Listing Rules 5635(c) and/or 5635(d), as applicable.
Added
All of the securities issued in the Note Exchange Transaction were offered and sold in reliance upon the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
The shares of Series M Preferred Stock were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
On or around September 9, 2025, the Company entered into securities purchase agreements (each a “PIPE Purchase Agreement” and collectively, the “PIPE Purchase Agreements”) with certain investors named therein (collectively, the “Purchasers”), pursuant to which the Company issued and sold to the Purchasers in a private placement an aggregate of approximately 951 shares of Series N Preferred Stock, for an aggregate purchase price of approximately $2.38 million.
Added
The shares of Series N Preferred Stock were issued in reliance upon exemptions from registration pursuant to 4(a)(2) under the Securities Act and Rule 506 of Regulation D promulgated thereunder.
Added
On September 28, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Brown Stone Capital Limited (“Brown Stone”), pursuant to which the Company issued and sold to Brown Stone (i) 161,583 shares of common stock and (ii) 479,442 pre-funded warrants (the “Pre-Funded Warrants”) to purchase shares of the Company’s common stock (the “Pre-Funded Warrant Shares” and together with the Shares and the Pre-Funded Warrants, the “Securities”).
Added
The Securities were offered and sold in reliance upon exemptions from registration pursuant to Section 4(a)(2) under the Securities Act and Rule 506 of Regulation D promulgated thereunder. On September 30, 2025, the Company entered into a privately negotiated exchange agreement with Streeterville.
Added
Pursuant to this agreement, the Company issued 286,532 shares of common stock to Streeterville in exchange for a $600,000 reduction in the outstanding balance of the royalty interest held by Streeterville. The shares of common stock that were issued in this exchange transaction were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
Upon completion of such exchange transaction, the exchanged Series M Preferred Stock were cancelled and retired. The common stock were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act.
Added
Upon completion of the First Exchange Transaction, such 75 shares of Series M Preferred Stock were cancelled and retired.
Added
On December 11, 2025, the Company entered into another privately negotiated exchange agreement with Iliad (the “Second Exchange Agreement” and together with the First Exchange Agreement, collectively the “Exchange Agreements”), pursuant to which the Company issued (i) 40,000 shares of common stock (the “Second Exchange Shares” and together with the First Exchange Shares, collectively the “Exchange Shares”) and (ii) a pre-funded common stock purchase warrant to purchase 304,827 shares of common stock (the “Second Pre-Funded Warrant” and together with the First Pre-Funded Warrant, collectively the “Pre-Funded Warrants”) to Iliad in 70 Table of Contents exchange for 16 shares of Series M Preferred Stock held by Iliad (the “Second Exchange Transaction”).
Added
Upon completion of the Second Exchange Transaction, such 16 shares of Series M Preferred Stock were cancelled and retired. Each of the Pre-Funded Warrants is exercisable in part or in full immediately at an exercise price of $0.001 per share, and may be exercised at any time until such Pre-Funded Warrant is exercised in full.
Added
The Pre-Funded Warrants provide that the number of shares that may be exercised shall be limited to ensure that, following such exercise, the number of shares of Common Stock beneficially owned by the holder, together with its affiliates and certain related parties, does not exceed 9.99% of the total number of shares of common stock then issued and outstanding.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

69 edited+86 added−42 removed22 unchanged
Biggest changeGeneral and Administrative Expense The following table presents the components of general and administrative (“G&A”) expense for the years ended December 31, 2024 and 2023: Year Ended December 31, (in thousands) 2024 2023 Variance Variance % General and Administrative: Personnel and related benefits $ 4,724 $ 5,135 $ (411 ) (8.0 ) % Legal services 1,805 2,009 (204 ) (10.2 ) % Public company expense 1,699 1,789 (90 ) (5.0 ) % Third-party consulting services 1,380 679 701 103.2 % Lease expense 817 877 (60 ) (6.8 ) % Stock-based compensation 781 916 (135 ) (14.7 ) % Audit, tax and accounting services 737 537 200 37.2 % Travel and other expenses 529 435 94 21.6 % Other 3,859 4,211 (352 ) (8.4 ) % Total $ 16,331 $ 16,588 $ (257 ) (1.5 ) % The change in G&A expenses of negative $257,000 for the year ended December 31, 2024 compared to 2023 was due primarily to: • Personnel and related benefits decreased by $411,000 from $5.1 million for the year ended December 31, 2023 to $4.7 million in the same period in 2024 due to reduction in headcount within the Finance and General Administration departments. • Legal services decreased by $204,000 from $2.0 million for the year ended December 31, 2023 to $1.8 million in the same period in 2024 primarily due to decreased legal consultations for contracts and agreements and other regulatory filings. • Third-party consulting services increased by $701,000 from $679,000 for the year ended December 31, 2023 to $1.4 million in the same period in 2024, mostly due to increase in headcount and business development activities related to Gelclair, an increase in accounting fees for complex accounting, and addition of new consultant for Napo Thera. • Stock-based compensation expense decreased by $135,000 from $916,000 for the year ended December 31, 2023 to $781,000 in the same period in 2024 due to fewer volume of stock incentive, options and RSUs granted during the period as compared to 2023.
Biggest changeGeneral and Administrative The following table presents the components of general and administrative (“G&A”) expense for the years ended December 31, 2025 and 2024, together with the change in such components in dollars and as a percentage: Year Ended December 31, (in thousands) 2025 2024 Variance Variance % General and Administrative: Personnel and related benefits $ 4,344 $ 4,724 $ (380 ) (8.0 ) % Legal services 3,813 1,805 2,008 111.2 % Depreciation and amortization 1,858 1,840 18 1.0 % Public company expense 2,327 1,699 628 37.0 % Third-party consulting services 1,414 1,380 34 2.5 % Audit, tax and accounting services 717 737 (20 ) (2.7 ) % Lease expense 511 817 (306 ) (37.5 ) % Stock-based compensation 451 781 (330 ) (42.3 ) % Travel and other expenses 623 529 94 17.8 % Other 2,586 2,019 567 28.1 % Total $ 18,644 $ 16,331 $ 2,313 14.2 % The increase in G&A expenses of $2.3 million for the year ended December 31, 2025 compared to 2024 was due primarily to: • Personnel and related benefits decreased by $380,000 from $4.7 million for the year ended December 31, 2024 to $4.3 million in the same period in 2025, largely due to the bonus paid in 2024 and none in 2025. • Legal services increased by $2.0 million from $1.8 million for the year ended December 31, 2024 to $3.8 million in the same period in 2025, due to corporate legal fees amounting to $1.3 million related to the licensing of Mytesi and Canalevia rights to Woodward Specialty, LLC.
Our Canalevia-CA1, Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers. • 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. • Revenues from a 5-year in-license agreement with United Kingdom-based Venture Life, from which the Company was granted the exclusive rights to market Venture Life's FDA-approved oral mucositis prescription product, Gelclair , within the US market. • Our policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired.
Our Canalevia-CA1, Neonorm and botanical extract products are primarily sold to distributors, who then sell the products to the end customers. • 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. • Revenues from a 5-year in-license agreement with United Kingdom-based Venture Life, from which the Company was granted the exclusive rights to market Venture Life's FDA-approved oral mucositis prescription product, Gelclair , within the US market. • Our policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired.
However, there can be no assurance that additional funding will be available to us on acceptable terms on a timely basis, if at all, or that we will generate sufficient cash from operations to adequately fund operating needs or ultimately achieve profitability.
However, there can be no assurance that additional funding will be available to us on acceptable terms on a timely basis, if at all, or that we will generate sufficient cash from operations to fund operating needs or ultimately achieve profitability adequately.
Cost of Revenue Cost of revenue consists of direct drug substance and drug product materials expense, direct labor, distribution fees, royalties and other related expenses associated with the sale of our products.
Cost of Product Revenue The cost of revenue consists of direct drug substance and drug product materials expenses, direct labor, distribution fees, royalties, and other related expenses associated with the sale of our products.
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 indications, including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults.
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.
These expenses include capital investments in seedling nurseries and tree planting. As of December 31, 2024, no significant non-recurring environmental remediation costs are anticipated. The Company continues to monitor its environmental impact and may incur future costs as needed.
These expenses include capital investments in seedling nurseries and tree planting. As of December 31, 2025, no significant non-recurring environmental remediation costs are anticipated. The Company continues to monitor its environmental impact and may incur future costs as needed.
We do not have significant marketing or promotional expenses related to Canalevia-CA1 and Neonorm Calf or Neonorm Foal for the years ended December 31, 2024 and 2023.
We do not have significant marketing or promotional expenses related to Canalevia-CA1 and Neonorm Calf or Neonorm Foal for the years ended December 31, 2025 and 2024.
Immediately following the Merger, Jaguar changed its name from 73 Table of Contents “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.
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.
This variation highlights the Company’s strategic focus on managing liquidity to maintain operational stability and pursue growth opportunities effectively. Analysis of Cost of Capital Resources Changes in market conditions may impact our cost of capital resources.
This variation highlights the Company’s strategic focus on managing liquidity to maintain operational stability and pursue growth opportunities effectively. 88 Table of Contents Analysis of Cost of Capital Resources Changes in market conditions may impact our cost of capital resources.
Sales and Marketing Expense 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.
Sales and Marketing Expense 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 78 Table of Contents expenses to promote Mytesi and Gelclair.
Liquidity Management As of December 31, 2024, the Company is actively monitoring trends in its capital resources, recognizing favorable and unfavorable developments that may materially impact its financial position. The Company has experienced an increase in debt levels due to recent financing activities intended to support operational growth.
Liquidity Management As of December 31, 2025, the Company is actively monitoring trends in its capital resources, recognizing favorable and unfavorable developments that may materially impact its financial position. The Company has experienced a substantial increase in debt levels due to recent financing activities intended to support operational growth.
Liquidity and Capital Resources Sources of Liquidity We have incurred net losses since our inception. For the years ended December 31, 2024 and 2023, we had net losses of $39.3 million and $41.9 million, respectively, and expect to incur additional losses in the near-term future due to significant expenses incurred related to the research and development phase.
Liquidity and Capital Resources Sources of Liquidity We have incurred net losses since our inception. For the years ended December 31, 2025 and 2024, we had net losses of $54.0 million and $39.3 million, respectively, and expect to incur additional losses in the near-term future due to significant expenses incurred related to the research and development phase.
Furthermore, the Company recognizes challenges related to liquidity. It has incurred recurring operating losses and negative cash flows, which raises uncertainties about its future liquidity. The ability to meet current obligations relies on successful ongoing development efforts and securing additional financing.
It has incurred recurring operating losses and negative cash flows, which raises uncertainties about its future liquidity. The ability to meet current obligations relies on successful ongoing development efforts and securing additional financing.
This program is being pursued with the potential targeted incentive from the FDA for a tropical disease priority review voucher.
This program is being pursued with the potential targeted incentive of a tropical disease review voucher from the FDA.
ITEM 7. MANAG EMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read together with our financial statements and the related notes appearing elsewhere in this report. Overview Jaguar Health, Inc.
ITEM 7. MANAG EMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read together with our financial statements and the related notes appearing elsewhere in this report. Overview Jaguar Health, Inc. (“Jaguar”), in conjunction with Jaguar family company Napo Pharmaceuticals, Inc.
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.
If a drug is designated as breakthrough therapy, the FDA will expedite the review timeline for the drug. 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.
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates accounted for $2.6 million and $2.0 million for the years ended December 31, 2024 and 2023, respectively, an increase of $523,000 due to higher product utilization within the program coupled changes in rebates agreements.
Medicaid and AIDS Drug Assistance Program (“ADAP”) rebates were $2.7 million and $2.6 million for the years ended December 31, 2025 and 2024, respectively, an increase of $141,000 due to higher product utilization within the program coupled with changes in rebate agreements.
During the year ended December 31, 2023, net cash used in operating activities of $33.2 million resulted from our net comprehensive loss of $41.9 million adjusted by amortization of debt issuance costs, debt discount, and non-cash interest expense of $13.2 million, change in fair value of freestanding and hybrid financial instruments designated at FVO of $5.1 million, stock-based compensation of $2.1 million, depreciation and amortization expenses of $2.0 million, amortization of operating lease right-of-use assets of $375,000, impairment loss on intangible asset of $371,000, shares issued in exchange for services of $171,000, share in joint venture’s loss of $51,000, gain on extinguishment of debt $3.7 million, and net changes in operating assets and liabilities of $11.1 million.
During the year ended December 31, 2024, net cash used in operating activities of $29.4 million resulted from our net comprehensive loss of $39.0 million adjusted by the change in fair value of freestanding and hybrid financial instruments designated at FVO of $9.5 million, depreciation and amortization expenses of $1.9 million, stock-based compensation of $1.6 million, amortization of operating lease right-of-use assets of $458,000, amortization of debt issuance costs, debt discount, and non-cash interest expense of $274,000, share in joint venture’s loss of $138,000, shares issued in exchange for services of $9,000, gain on extinguishment of debt $1.2 million, and net changes in operating assets and liabilities of $3.0 million.
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.
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.
Cash Provided by Financing Activities During the year ended December 31, 2024, net cash provided by financing activities of $31.2 million consisted of $30.8 million in net proceeds from shares issued in an At the Market offering, $1.2 million proceeds from the issuance of common shares in exchange of License Agreement, offset by $608,000 repayment of insurance financing, and $100,000 in principal payments of the notes payable.
During the year ended December 31, 2024, net cash provided by financing activities of $31.2 million consisted of issuance of an aggregate of 388,636 shares of common stock under the ATM Agreement for total net proceeds of approximately $30.8 million, $1.2 million proceeds from the issuance of common shares in exchange of License Agreement, offset by $608,000 repayment of insurance financing, and $100,000 in principal payments of the notes payable.
At December 31, 2024, we had an accumulated deficit of $346.5 million and accumulated comprehensive loss of $467,000. We continue our efforts to develop our products and continue the development of our pipeline in the near term and to date, we have generated only limited revenues. As of December 31, 2024, we had cash of $8.0 million.
At December 31, 2025, we had an accumulated deficit of $399.9 million and accumulated comprehensive loss of $833,000. We continue our efforts to develop our products and continue the development of our pipeline in the near term and to date, we have generated only limited revenues. As of December 31, 2025, we had cash of $968,000.
Change in Fair Value of Freestanding and Hybrid Financial Instruments Designated at FVO The fair value of financial instrument and hybrid instrument designated at FVO increased by $4.4 million, from a loss of $5.1 million in year ended December 31, 2023, to a loss of $9.5 million in the same period in 2024 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
Change in Fair Value of Freestanding and Hybrid Financial Instruments Designated at FVO The fair value of financial instrument and hybrid instrument designated at FVO decreased by $3.2 million, from a loss of $9.5 million in year ended December 31, 2024, to a loss of $6.3 million in the same period in 2025, primarily due to fair value adjustments in notes payable designated at FVO.
Payments of cash compensation to directors under the Director Compensation Program for the year ended December 31, 2024 amounted to $442,495.
Payments of cash compensation to directors under the Director Compensation Program for the year ended December 31, 2025 amounted to $431,000.
However, while operating cash flows benefited from these reductions, the ongoing significant variation between operating income and operating cash flows, highlights challenges in achieving cash flow positivity due to high non-cash charges, such as depreciation and stock-based compensation, alongside increased working capital needs to support expanded operations.
The ongoing significant variation between net loss and operating cash flows, highlights challenges in achieving cash flow positivity due to high non-cash charges, such as provision for inventory obsolescence, depreciation and stock-based compensation, alongside increased working capital needs to support expanded operations.
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.
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.
Rising interest rates could increase our cost of debt, while seeking equity financing may lead to higher required returns on equity due to potential dilution.
Rising interest rates could increase our cost of debt, while seeking equity financing may lead to higher required returns on equity due to potential dilution. We will actively monitor these factors as part of our financial strategy.
In the near term, we expect general and administrative expense to remain flat as we focus on our pipeline development and market access expansion. This will include efforts to grow the business. Interest Expense Interest expense consists primarily of non-cash and cash interest costs related to our borrowings.
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. Interest Expense Interest expense consists primarily of non-cash and cash interest costs related to our borrowings.
In contrast, equity levels remain stable, though future fundraising efforts may affect the capital structure. The Company expects changes in the mix of capital resources, particularly concerning the relative costs of debt versus equity financing. Current market conditions indicate a trend of rising interest rates, which may increase the cost of future debt issuances.
The Company expects changes in the mix of capital resources, particularly concerning the relative costs of debt versus equity financing. Current market conditions indicate a trend of rising interest rates, which may increase the cost of future debt issuances. Furthermore, the Company recognizes challenges related to liquidity.
We typically use our employee and infrastructure resources across multiple development programs. We track outsourced development costs by prescription drug product candidate and non‑prescription product but do not allocate personnel or other internal costs related to development to specific programs or development compounds. As of December 31, 2024, the Company has incurred approximately $6.1 million on its primary R&D projects.
We track outsourced development costs by prescription drug product candidate and non-prescription product, and we track personnel or other internal costs related to the development of specific programs or development compounds. As of December 31, 2025, the Company has incurred approximately $25.0 million on its primary R&D projects.
For additional information relating to these and other accounting policies, see Note 2 to the consolidated financial statements, appearing elsewhere in this report. Potential Material Effects of Trends, Events, and Uncertainties Inflation Reduction Act The Inflation Reduction Act, effective January 1, 2023, introduces several provisions that may impact the Company's operations and financial results.
For additional information relating to these and other accounting policies, see Note 2 to the consolidated financial statements, appearing elsewhere in this report. Potential Material Effects of Trends, Events, and Uncertainties Inflation and the Inflation Reduction Act (IRA) The Company continues to monitor the effects of ongoing inflationary pressures and the IRA, which became effective on January 1, 2023.
We will actively monitor these factors as part of our financial strategy. 85 Table of Contents Cash Flows for Year Ended December 31, 2024 compared to the Year Ended December 31, 2023 The following table shows a summary of cash flows for the years ended December 31, 2024 and 2023: Year Ended December 31, (in thousands) 2024 2023 Total cash used in operating activities $ (29,384 ) $ (33,242 ) Total cash used in investing activities (231 ) — Total cash provided by financing activities 31,202 34,227 Effects of foreign exchange rate changes on assets and liabilities (54 ) 15 Net increase in cash $ 1,533 $ 1,000 Cash Used in Operating Activities During the year ended December 31, 2024, net cash used in operating activities of $29.4 million resulted from our net comprehensive loss of $39.0 million adjusted by the change in fair value of freestanding and hybrid financial instruments designated at FVO of $9.5 million, depreciation and amortization expenses of $1.9 million, stock-based compensation of $1.6 million, amortization of operating lease right-of-use assets of $458,000, amortization of debt issuance costs, debt discount, and non-cash interest expense of $274,000, share in joint venture’s loss of $138,000, shares issued in exchange for services of $9,000, gain on extinguishment of debt $1.2 million, and net changes in operating assets and liabilities of $3.0 million.
Cash Flows for Year Ended December 31, 2025 compared to the Year Ended December 31, 2024 The following table shows a summary of cash flows for the years ended December 31, 2025 and 2024: Year Ended December 31, (in thousands) 2025 2024 Total cash used in operating activities $ (23,686 ) $ (29,384 ) Total cash used in investing activities (41 ) (231 ) Total cash provided by financing activities 23,670 31,202 Effects of foreign exchange rate changes on assets and liabilities (113 ) (54 ) Net increase (decrease) in cash and restricted cash $ (170 ) $ 1,533 Cash Used in Operating Activities During the year ended December 31, 2025, net cash used in operating activities of $23.7 million resulted from our net comprehensive loss of $54.4 million adjusted by the change in fair value of freestanding and hybrid financial instruments designated at FVO of $6.3 million, provision for inventory obsolescence of $2.0 million, depreciation and amortization expenses of $1.9 million, loss on extinguishment of debt $1.8 million, stock-based compensation of $831,000, impairment loss on indefinite-lived intangible assets of $800,000, amortization of operating lease right-of-use assets of $289,000, share in joint venture’s loss of $162,000, amortization of debt issuance costs, debt discount, and non-cash interest expense of $153,000, and net changes in operating assets and liabilities of $16.5 million.
Research and Development Expense Research and development expenses consist primarily of clinical and contract manufacturing expense, personnel and related benefit expense, stock‑based compensation expense, employee travel expense and reforestation 76 Table of Contents expenses.
Research and Development 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.
Gain or Loss on Extinguishment of Debt Gain on extinguishment of debt decreased by $2.5 million from a gain of $3.7 million gain for the year ended December 31, 2023 to a gain of $1.2 million for the same period in 2024 primarily due to significant modifications of royalty interest agreements resulting to extinguishment accounting.
Gain or Loss on Extinguishment of Debt Loss on extinguishment of debt increased by $3.0 million from a gain of $1.2 million gain for the year ended December 31, 2024 to a loss of $1.8 million for the same period in 2025, primarily due to substantial modifications to the expected payments of one royalty interest agreement, which triggered extinguishment accounting.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the Company’s results of operations with respect to the items set forth in such table for the years ended December 31, 2024 and 2023, together with the change in such items in dollars and as a percentage.
Effective management of these lease liabilities will be essential for ensuring operational flexibility and financial stability in the upcoming years. 80 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes the Company’s results of operations with respect to the items set forth in such table for the years ended December 31, 2025 and 2024, together with the change in such items in dollars and as a percentage.
To address these liquidity concerns, the Company is committed to pursuing all available avenues for financing and will continuously assess its capital structure and operational needs to ensure financial stability.
To address these liquidity concerns, the Company is committed to pursuing all available avenues for financing and will continuously assess its capital structure and operational needs to ensure financial stability. Comparison of Operating Loss and Cash Flow For the year ended December 31, 2025, the Company’s operating cash flows showed a decline over the prior period.
The FDA conditionally approves 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.
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.
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 2025 while the company pursues approval of crofelemer for SBS and MVID from the EMA and the FDA.
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.
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 a year and still have the use qualify as a minor use.
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. 75 Table of Contents 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.
Deductions to reduce gross product sales to net product sales for the years ended December 31, 2024 and 2023 are as follows: Year Ended December 31, (in thousands) 2024 2023 Variance Variance % Gross product sales Mytesi $ 15,218 $ 13,435 $ 1,783 13.3 % Canalevia 160 130 30 23.1 % Gelclair 49 — 49 100.0 % Neonorm 28 42 (14 ) (33.3 ) % Total gross product sales 15,455 13,607 1,848 13.6 % Medicaid rebates (2,564 ) (2,041 ) (523 ) 25.6 % Sales discounts (1,149 ) (1,449 ) 300 (20.7 ) % Sales returns (182 ) (356 ) 174 (48.9 ) % Product revenue, net $ 11,560 $ 9,761 $ 1,799 18.4 % Product revenue Our gross product revenues were $15.5 million and $13.6 million for the years ended December 31, 2024 and 2023, respectively.
Deductions to reduce gross product sales to net product sales for the years ended December 31, 2025 and 2024 are as follows: Year Ended December 31, (in thousands) 2025 2024 Variance Variance % Gross product sales Mytesi $ 15,002 $ 15,218 $ (216 ) (1.4 ) % Canalevia 148 160 (12 ) (7.5 ) % Gelclair 140 49 91 185.7 % Neonorm 35 28 7 25.0 % Total gross product sales 15,325 15,455 (130 ) (0.8 ) % Medicaid rebates (2,705 ) (2,564 ) (141 ) 5.5 % Sales discounts (1,260 ) (1,149 ) (111 ) 9.7 % Sales returns (21 ) (182 ) 161 (88.5 ) % Net product sales $ 11,339 $ 11,560 $ (221 ) (1.9 ) % Our gross product revenues were approximately $15.3 million and $15.5 million for the years ended December 31, 2025 and 2024, respectively.
If we do not generate upfront fees from any anticipated arrangements, it would have a negative effect on our operating plan. We still plan to finance our operations and capital funding needs through equity and/or debt financing as well as revenue from future product sales.
We still plan to finance our operations and capital funding needs through equity and debt financing as well as revenue from future product sales.
Cash Used in Investing Activities During the year ended December 31, 2024, cash used in investing activities of $231,000 consisted of a $16,000 purchase of equipment and purchase of intangible asset of $215,000. This reflects management's commitment to maintaining liquidity, as there were no cash outflows for investing activities in the prior year.
Cash Used in Investing Activities During the year ended December 31, 2025, cash used in investing activities of $41,000 consisted of purchase of furniture and fixtures. During the year ended cash used in investing activities of $231,000 consisted of a $16,000 purchase of equipment and purchase of intangible asset of $215,000.
As part of our strategy to expand our commercial footprint beyond 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.
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.
Napo’s marketed drug Mytesi (crofelemer 125 mg delayed-release tablets) is a first-in-class oral botanical drug product approved by the US Food and Drug Administration (“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.
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.
We expect sales and marketing expenses to increase going forward as we focus on expanding our market access activities and commercial partnerships to develop follow-on indications of Mytesi, Gelclair and crofelemer. 77 Table of Contents General and Administrative Expense 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.
Thus, we expect no sales and marketing expenses for these products going forward. General and Administrative Expense 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.
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 in the FDA’s Breakthrough Therapies program.
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.
FDA has established a “small number” threshold for minor use in each of the seven major species covered by 75 Table of Contents the MUMS Act.
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.
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.
In October 2024, Jaguar initiated the commercial launch of Gelclair, the Company’s third commercialized prescription product, in the US. 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.
We may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. We may also not be successful in entering into partnerships that include payment of upfront licensing fees for our products and product candidates for markets outside the US, where appropriate.
We expect our expenditures will continue to increase as we continue our efforts to develop our products and continue the development of our pipeline in the near term. We may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
Research and Development Expense The following table presents the components of research and development (“R&D”) expense for the years ended December 31, 2024 and 2023: Year Ended December 31, (in thousands) 2024 2023 Variance Variance % Research and Development: Personnel and related benefits $ 6,713 $ 5,815 $ 898 15.4 % Clinical and contract manufacturing 6,068 8,155 (2,087 ) (25.6 ) % Stock-based compensation 711 1,044 (333 ) (31.9 ) % Materials expense and tree planting 345 367 (22 ) (6.0 ) % Travel and other expenses 204 326 (122 ) (37.4 ) % Other 2,501 2,889 (388 ) (13.4 ) % Total $ 16,542 $ 18,596 $ (2,054 ) (11.0 ) % 81 Table of Contents The change in R&D expense of $2.1 million for the year ended December 31, 2024 compared to 2023 was primarily due to: • Personnel and related benefits increased by $898,000 from $5.8 million for the year ended December 31, 2023 to $6.7 million in the same period in 2024 due to new internship program and employee promotions, increasing payroll and benefits expenses. • Clinical and contract manufacturing expenses decreased by $2.1 million from $8.2 million for the year ended December 31, 2023 to $6.1 million in the same period in 2024 as the Phase 3 On Target Clinical Trial concluded, reducing the clinical trial-related costs and external contract manufacturing services. • Stock-based compensation expense decreased by $333,000 from $1.0 million for the year ended December 31, 2023 to $711,000 in the same period in 2024 due to fewer volume of stock incentive, options and RSUs granted during the period as compared to 2023.
Research and Development The following table presents the components of R&D expense for the years ended December 31, 2025 and 2024, together with the change in such components in dollars and as a percentage: Year Ended December 31, (in thousands) 2025 2024 Variance Variance % Research and Development: Clinical and contract manufacturing $ 15,964 $ 6,068 $ 9,896 163.1 % Personnel and related benefits 5,994 6,713 (719 ) (10.7 ) % Materials expense and tree planting 338 345 (7 ) (2.0 ) % Stock-based compensation 269 711 (442 ) (62.2 ) % Travel and other expenses 220 204 16 7.8 % Other 2,181 2,501 (320 ) (12.8 ) % Total $ 24,966 $ 16,542 $ 8,424 50.9 % 83 Table of Contents The increase in R&D expense of $8.4 million for the year ended December 31, 2025 compared to 2024 was primarily due to: • Clinical and contract manufacturing expenses increased by $9.9 million from $6.1 million for the year ended December 31, 2024 to $16.0 million in the same period in 2025.
Sales and Marketing Expense The following table presents the components of sales and marketing (“S&M”) expense for the years ended December 31, 2024 and 2023: Year Ended December 31, (in thousands) 2024 2023 Variance Variance % Sales and Marketing: Personnel and related benefits $ 3,449 $ 3,025 $ 424 14.0 % Direct marketing fees and expense 2,407 1,903 504 26.5 % Stock-based compensation 149 152 (3 ) (2.0 ) % Other 1,687 1,380 307 22.2 % Total $ 7,692 $ 6,460 $ 1,232 19.1 % The change in S&M expense of $1.2 million for the year ended December 31, 2024 compared to 2023 was primarily due to: • Personnel and related benefits increased by $424,000 from $3.0 million for the year ended December 31, 2023 to $3.4 million in the same period in 2024 due to additional headcount in relation to Gelclair, a new product launched in the fourth quarter of 2024, bonus paid, and increased in salary and cost of health benefits. • Direct marketing fees and expense increased by $504,000 from $1.9 million for the year ended December 31, 2023 to $2.4 million in the same period in 2024 due to reduced patient access programs and other Mytesi marketing initiatives, in line with reduction in budgets and discontinuance of some general marketing programs and additional services for the promotion of Gelclair, a new product launched in fourth quarter of 2024. 82 Table of Contents • Other expenses consisting of third-party fees and travel expenses increased by $307,000 from $1.4 million for the year ended December 31, 2023 to $1.7 million in the same period in 2024 due to expanded market access activities and commercial partnerships.
Sales and Marketing The following table presents the components of sales and marketing (“S&M”) expense for the years ended December 31, 2025 and 2024, together with the change in such components in dollars and as a percentage: Year Ended December 31, (in thousands) 2025 2024 Variance Variance % Sales and Marketing: Personnel and related benefits $ 4,955 $ 3,449 $ 1,506 43.7 % Direct marketing fees and expense 2,744 2,407 337 14.0 % Stock-based compensation 111 149 (38 ) (25.5 ) % Other 1,425 1,687 (262 ) (15.5 ) % Total $ 9,235 $ 7,692 $ 1,543 20.1 % The increase in S&M expense of $1.5 million for the year ended December 31, 2025 compared to 2024 was primarily due to: • Personnel and related benefits increased by $1.5 million from $3.4 million for the year ended December 31, 2024 to $5.0 million in the same period in 2025, due to additional headcount for the Gelclair sales team after their product launch in 2024, resulting in increased cost of compensation, health benefits, and commissions paid. 85 Table of Contents • Other sales and marketing expenses decreased by $262,000 from $1.7 million for the year ended December 31, 2024 to $1.4 million in the same period in 2025, due to the absence of recruiting fees as no additional personnel hiring was required during the year and decreased consulting fees.
The increase in gross product revenue of $1.8 million for the years ended December 31, 2024, compared to the same period in 2023 was primarily due to the increase in price of Mytesi and Canalevia-CA1, an increase to $15.2 million and $160,000, respectively.
The decrease in gross product revenue of $130,000 for the year ended December 31, 2025 compared to the same period in 2024, was primarily due to the decrease in sales volume of Mytesi and Canalevia-CA1. The Company launched Gelclair during the third quarter of 2024, and recognized $140,000 in revenue for the year ended December 31, 2025.
Net cash provided by financing activities of $31.2 million in 2024, primarily from an ATM offering and share issuance related to licensing agreement. This trend underscores the Company's ongoing necessity to leverage external financing to address cash flow shortfalls from operations.
This trend underscores the Company's ongoing necessity to leverage external financing to address cash flow shortfalls from operations.
(“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 conditions. Jaguar was founded in San Francisco, California as a Delaware corporation on June 6, 2013 (inception).
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 was founded in San Francisco, California, as a Delaware corporation on June 6, 2013 (“inception”).
If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of the drug. Crofelemer was granted Orphan Drug Designation (“ODD”) by the FDA in February 2023 for MVID and granted ODD for MVID by the European Medicines Agency (“EMA”) in October 2022.
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.
Additionally, several drug product opportunities in Jaguar’s crofelemer pipeline are backed by Phase 2 and POC evidence from human clinical trials. Financial Operations Overview On a consolidated basis, we have not yet generated enough revenue to date to achieve break-even or positive cash flow, and we expect to continue to incur significant research and development and other expenses.
Financial Operations Overview On a consolidated basis, we have not yet generated enough revenue to date to achieve break-even or positive cash flow, and we expect to continue to incur significant research and development and other expenses. Our net comprehensive losses were $54.4 million and $39.0 million for the years ended December 31, 2025 and 2024, respectively.
We expect research and development expenses to decrease as the Phase 3 OnTarget Trial concluded; though we expect start-up costs associated with our clinical trials for other indications. Materials expense and tree planting refers to the Company's ongoing environmental costs related to the sustainable sourcing of crofelemer and reforestation activities in the Amazon Rainforest.
Following FDA clearance for this new study in metastatic breast cancer patients, the costs associated with the clinical trial conduct will incur in the succeeding months in 2026. Materials expense and tree planting refers to the Company's ongoing environmental costs related to the sustainable sourcing of crofelemer and reforestation activities in the Amazon Rainforest.
Year Ended December 31, (in thousands) 2024 2023 Variance Variance % Product revenue, net $ 11,560 $ 9,761 $ 1,799 18.4 % License revenue 129 — 129 100.0 % Total revenue 11,689 9,761 1,928 19.8 % Operating expenses Cost of product revenue 1,955 2,037 (82 ) (4.0 ) % Research and development 16,542 18,596 (2,054 ) (11.0 ) % Sales and marketing 7,692 6,460 1,232 19.1 % General and administrative 16,331 16,588 (257 ) (1.5 ) % Impairment loss on intangible assets — 371 (371 ) (100.0 ) % Total operating expenses 42,520 44,052 (1,532 ) (3.5 ) % Loss from operations (30,831 ) (34,291 ) 3,460 (10.1 ) % Interest expense (231 ) (6,382 ) 6,151 (96.4 ) % Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option (9,485 ) (5,125 ) (4,360 ) 85.1 % Gain on extinguishment of debt 1,245 3,697 (2,452 ) (66.3 ) % Other income 51 200 (149 ) (74.5 ) % Loss before income tax expense (39,251 ) (41,901 ) 2,650 (6.3 ) % Income tax expense — — — — % Net loss $ (39,251 ) $ (41,901 ) $ 2,650 (6.3 ) % Net loss attributable to noncontrolling interest $ (759 ) $ (601 ) $ (158 ) 26.3 % Net loss attributable to common stockholders $ (38,492 ) $ (41,300 ) $ 2,808 (6.8 ) % 79 Table of Contents Revenue License revenue License revenues increased by $129,000 from $0 for the year ended December 31, 2023 to $129,000 in the same period in 2024, due to license agreement entered by the Company with GEN on March 18, 2024.
Year Ended December 31, (in thousands) 2025 2024 Variance Variance % Product revenue, net $ 11,339 $ 11,560 $ (221 ) (1.9 ) % License revenue 172 129 43 33.3 % Total revenue 11,511 11,689 (178 ) (1.5 ) % Operating expenses Cost of product revenue 3,774 1,955 1,819 93.0 % Research and development 24,966 16,542 8,424 50.9 % Sales and marketing 9,235 7,692 1,543 20.1 % General and administrative 18,644 16,331 2,313 14.2 % Impairment loss on indefinite-lived intangible assets 800 — 800 100.0 % Total operating expenses 57,419 42,520 14,899 35.0 % Loss from operations (45,908 ) (30,831 ) (15,077 ) 48.9 % Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option (6,266 ) (9,485 ) 3,219 (33.9 ) % Gain (loss) on extinguishment of debt (1,799 ) 1,245 (3,044 ) (244.5 ) % Interest income (expense) (67 ) (231 ) 164 (71.0 ) % Other income (expense) 43 51 (8 ) (15.7 ) % Loss before income tax expense (53,997 ) (39,251 ) (14,746 ) 37.6 % Income tax expense — — — — % Net loss $ (53,997 ) $ (39,251 ) $ (14,746 ) 37.6 % Net loss attributable to noncontrolling interest $ (563 ) $ (759 ) $ 196 (25.8 ) % Deemed dividend to preferred stockholders $ 141 $ — $ 141 100.0 % Net loss attributable to common stockholders $ (53,575 ) $ (38,492 ) $ (15,083 ) 39.2 % 81 Table of Contents Revenue Product revenue 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.
Sales returns were $182,000 and $356,000 for the years ended December 31, 2024 and 2023, respectively, a decrease of $174,000, relatively due to enhanced manufacturing process as compared to year 2023. 80 Table of Contents Cost of Product Revenue Year Ended December 31, (in thousands) 2024 2023 Variance Variance % Cost of Product Revenue Direct labor $ 896 $ 1,152 $ (256 ) (22.2 ) % Material cost 796 885 (89 ) (10.1 ) % Distribution fees 186 (49 ) 235 (479.6 ) % Other 77 49 28 57.1 % Total $ 1,955 $ 2,037 $ (82 ) (4.0 ) % The change in cost of product revenue of $82,000 for the year ended December 31, 2024 compared to 2023 was primarily due to: • Direct labor decreased by $256,000 from $1.2 million for the year ended December 31, 2023 to $896,000 in the same period in 2024, due to decrease in resources spent in testing and manufacturing of inventory. • Distribution fees increased by $235,000 from negative $49,000 for the year ended December 31, 2023, to $186,000 in the same period in 2024, due to the increase in warehouse fees driven by the increase in sales volume for Mytesi. • Other costs increased by $28,000 from $49,000 for the year ended December 31, 2023 to $77,000 in the same period in 2024 due to increase in royalties for Mytesi and Gelclair products, which are directly related to the increase in sales.
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 5 years. 82 Table of Contents Cost of Product Revenue Year Ended December 31, (in thousands) 2025 2024 Variance Variance % Cost of Product Revenue Direct labor $ 556 $ 896 $ (340 ) (37.9 ) % Material cost 903 796 107 13.4 % Distribution fees 125 186 (61 ) (32.8 ) % Other 2,190 77 2,113 2,744.2 % Total $ 3,774 $ 1,955 $ 1,819 93.0 % The increase in cost of product revenue of $1.8 million for the year ended December 31, 2025 compared to 2024 was primarily due to: • Direct labor decreased by $340,000 from $896,000 for the year ended December 31, 2024 to $556,000 in the same period in 2025, due to a decrease in resources spent in testing and manufacturing of inventory. • Material cost increased by $107,000 from $796,000 for the year ended December 31, 2024 to $903,000 in the same period in 2025, due to higher average unit cost of the bottle lot sold for Mytesi, which increased from approximately $89 in 2024 to $119 in 2025.
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, is a key asset we have generated over 30 years that bridges the knowledge of traditional healers and Western medicine.
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. In the field of animal health, Jaguar Animal Health is continuing limited activities related to developing first-in-class gastrointestinal products for dogs.
Our net comprehensive losses were $39.0 million and $41.9 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had total stockholders' equity of $6.5 million, an accumulated deficit of $346.5 million, an accumulated other comprehensive loss of $467,000 and cash of $8.0 million.
As of December 31, 2025, we had total stockholders' deficit of $18.7 million, an accumulated deficit of $399.9 million, an accumulated other comprehensive loss of $833,000 and cash of $968,000.
During the year ended December 31, 2023, net cash provided by financing activities of $34.2 million consisted of $32.1 million in net proceeds from shares issued in an At the Market offering, $1.2 million net proceeds from issuance of warrants in PIPE financing, investment from non-controlling interest of $1.2 million and $611,000 net proceeds from issuance of preferred shares in PIPE financing, offset by $853,000 repayment of insurance financing, and $100,000 in principal payments of Tempesta Note. 86 Table of Contents
Cash Provided by Financing Activities During the year ended December 31, 2025, net cash provided by financing activities of $23.7 million consisted of $10.0 million proceeds from New Note from Streeterville, issuance of an aggregate of 2,159,049 shares of common stock under the ATM Agreement for total net proceeds of approximately $6.3 million, $3.4 million proceeds from Convertible Notes, $2.4 million in net proceeds from shares issued in PIPE financing, $1.3 million in net proceeds from shares issued to placement agent, $1.0 million in net proceeds from shares issued to Brown Stone Capital Limited, offset by $652,000 repayment of insurance financing, and $100,000 in principal payments of the notes payable. 89 Table of Contents Net cash provided by financing activities of $23.7 million in 2025, primarily from ATM offerings and issuance of New Note from Streeterville.
Jaguar is currently supporting three proof-of-concept (POC) investigator-initiated trials (IIT), and conducting two Phase 2 studies, of crofelemer for the rare diseases short bowel syndrome (SBS) with intestinal failure and/or MVID in the US, EU, and/or Middle East/North Africa regions.
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.
Gain on Debt Extinguishment Gain on debt extinguishment represents gains recognized related to the modifications, settlements, or exchanges of our borrowings that result in the derecognition of the original obligations.
Gain (Loss) on Debt Extinguishment Gain (loss) on debt extinguishment consists of gain (loss) incurred related to the exchanges resulting from the extinguishment of our borrowings.
The Company launched Gelclair during the third quarter of 2024, and recognized $49,000 in revenue for the year ended December 31, 2024. Sales discounts were $1.1 million and $1.4 million for the years ended December 31, 2024 and 2023, respectively, a decrease of $300,000 due to operational efficiencies and enhanced inventory management process.
Sales returns were $21,000 and $182,000 for the years ended December 31, 2025 and 2024, respectively, a decrease of $161,000 due to the decrease in volume of sales returns.
Cash provided by financing activities for the year ended December 31, 2024, were generated from the issuance of an aggregate of 388,634 shares of common stock under the ATM Agreement for total net proceeds of approximately $30.8 million, and issuance of an aggregate 11,111 common stock in exchange of License Agreement for total net proceeds of $1.2 million. 84 Table of Contents We expect our expenditures will continue to increase as we continue our efforts to develop our products and continue the development of our pipeline in the near term.
Cash provided by financing activities for the year ended December 31, 2025, were generated 87 Table of Contents from $10.0 million proceeds from New Note from Streeterville, issuance of an aggregate of 2,159,049 shares of common stock under the ATM Agreement for total net proceeds of approximately $6.3 million, $3.4 million proceeds from Convertible Notes, $2.4 million in net proceeds from shares issued in PIPE financing, $1.3 million in net proceeds from shares issued to placement agents, $1.0 million in net proceeds from shares issued to Brown Stone Capital Limited, offset by $652,000 repayment of insurance financing, and $100,000 in principal payments of the notes payable.
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.
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.
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 numbing agent and does not sting 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.
Clinical and contract manufacturing expense consists primarily of costs to conduct stability, safety and efficacy studies, and manufacturing startup expenses at an outsourced API provider in Italy. It also includes expenses with a third-party provider for the transfer of the Mytesi manufacturing process, and the related feasibility and validation activities.
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. 77 Table of Contents We capitalize certain tangible research and development materials, such as API and intermediate lyophilized products, that have a probable alternative future use.
The Company’s Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients has been initiated, as has the Company’s Phase 2 study to evaluate the efficacy of crofelemer for SBS with intestinal failure (SBS-IF) in adults, the independent IIT of crofelemer in pediatric patients with SBS-IF or MVID in Abu Dhabi in the United Arab Emirates, and the independent IIT in the US to evaluate crofelemer for SBS-IF in adults.
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.
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(“Jaguar” or the “Company”) is a commercial-stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with gastrointestinal (“GI”) distress, including chronic, debilitating diarrhea. Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc.
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(“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.
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(“Napo”), focuses on developing and commercializing proprietary plant-based human prescriptions from plants for essential supportive care and management of neglected GI symptoms across multiple complicated disease states. Our crofelemer drug product candidate is the subject of the OnTarget study, a recently conducted pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy.
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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.
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The recently completed analysis 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 unprecedented prophylactic clinical trial in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.
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Jaguar was provided with $16 million of non-dilutive capital in January 2026 upon closing of the agreement with Future Pak, with an additional $2 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.
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The OnTarget results in breast cancer 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 in breast cancer patients in OnTarget, potentially helping them stay on their cancer therapies.
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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.
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This research underscores the potential of crofelemer for prophylaxis of cancer therapy-related diarrhea (“CTD”). A full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal.
Added
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.
Removed
Jaguar is 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 access in Europe.

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