US Market News
1週前
Jaguar Health Presenting June 24, 2026 at the Life Sciences Virtual Investor Forum to Provide Updates on Company's Crofelemer Development Program for Rare Intestinal Failure DiseasesJune 12, 2026 9:00 AM
ACCESS NewswireClick here to register for eventTo access the replay of the June 10, 2026 presentation by Lisa Conte, Jaguar's founder, president & CEO, at the Emerging Growth Conference, click hereReminder: Two crofelemer presentations in pediatric intestinal failure patients with microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) to be conducted at June 24-27, 2026 Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) MeetingSAN FRANCISCO, CA / ACCESS Newswire / June 12, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present virtually on Wednesday, June 24, 2026 at the Life Sciences Virtual Investor Forum hosted by VirtualInvestorConferences.com.Participation Instructions for Jaguar's Presentation at the Life Sciences Virtual Investor ForumWhen: Wednesday, June 24, 2026 at 1:00 PM EasternRegistration link for conference: Click HereReplay: A replay of the webcast will be available following the conclusion of the conference.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the June 2026 conference listed above, and the expectation that two crofelemer-related presentations in pediatric intestinal failure patients with MVID and SBS-IF will be made at the 58th ESPGHAN Annual Meeting in June 2026. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:
hello@jaguar.healthSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Presenting June 24, 2026 at the Life Sciences Virtual Investor Forum to Provide Updates on Company's Crofelemer Development Program for Rare Intestinal Failure Diseases
US Market News
2週前
Jaguar Health Reports Approval of All Proposals at 2026 Annual Meeting of StockholdersJune 8, 2026 4:15 PM
ACCESS NewswireLisa Conte, Jaguar's founder, president & CEO, presenting virtually on June 10, 2026 at the Emerging Growth Conference; click here to registerSAN FRANCISCO, CA / ACCESS Newswire / June 8, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's May 22, 2026 Annual Meeting of Stockholders (the "Annual Meeting"), which was adjourned until June 8, 2026.Five proposals were submitted to and approved by the stockholders of the Company at the Annual Meeting. The proposals are described in detail in the Company's definitive proxy statement on Schedule 14A relating to the Annual Meeting filed with the Securities and Exchange Commission (the "SEC") on April 30, 2026 and supplemental information filed with the SEC. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company's corporate website.Participation Instructions for Jaguar's Virtual Presentation at the Emerging Growth ConferenceWhen: Wednesday, June 10, 2026 from 12:35 - 1:05 PM EasternWhere: Online (Click Here)Registration link for conference: Click HereReplay: An archived webcast of the presentation will be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the June 2026 Emerging Growth Conference. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Source: Jaguar Health, Inc.Contact:hello@jaguar.healthJaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Reports Approval of All Proposals at 2026 Annual Meeting of Stockholders
US Market News
3週前
Jaguar Health Research in Ethnobotanical Medicine Helps Advance Crofelemer Development for Genetically Defined Rare Congenital Gastrointestinal DisordersMay 28, 2026 10:00 AM
ACCESS NewswireCrofelemer delayed-release tablets are Jaguar's FDA-approved prescription drug under botanical guidance ("botanical drug") derived from the Croton lechleri tree. Crofelemer, in a novel liquid formulation, is being developed as the potential first oral adjunctive therapy for Intestinal Failure (IF) from microvillus inclusion disease (MVID) and short bowel syndrome (SBS)Crofelemer development with novel formulations for different gastrointestinal disorders reflects a differentiated botanical drug platform integrating ethnobotanical medicine, sustainable harvesting, complex CMC, and novel bioassays to support approval under FDA botanical guidanceTraditional knowledge of Croton lechleri use supported ethnobotanical research that led to development and approval of crofelemer, whose first in class anti-secretory mechanism was characterized through modern pharmacology and mechanism-based bioassays. Recent milestones include continued evaluation in an extension phase for Jaguar family company Napo's pivotal clinical trial of crofelemer as adjunctive therapy to Parenteral Support (PS) for MVID and upcoming ESPGHAN presentations in pediatric MVID and SBS-IF patientsFDA approval of crofelemer as an oral botanical drug highlights the totality-of-evidence and creates a significant practical barrier to generic replicationSAN FRANCISCO, CA / ACCESS Newswire / May 28, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) and family company Napo Pharmaceuticals (Napo) today highlighted how the Company's long-standing research in ethnobotanical medicine, sustainable harvesting, and regulatory drug development under botanical guidance ("botanical drug") continues to inform the development of crofelemer as a novel oral adjunctive therapy to PS for rare congenital gastrointestinal intestinal failure (IF) disorders, including microvillus inclusion disease (MVID) and short bowel syndrome (SBS).It has been through direct research collaboration with indigenous experts on plant and ethnobotanical medicine that Napo team members learned about the use of extracts of Croton lechleri to treat a number of gastrointestinal conditions. We have had cross-cultural medical discussions with traditional healers - a methodology that provides an opportunity to elucidate new ways of treating unmet medical needs such as IF. Napo has been collaborating on the long term sustainable harvest of Croton lechleri in the Central and Northern Peruvian Amazon for several decades, and this is being done with 19 distinct indigenous cultural groups in more than 30 locations.Crofelemer is a refined and highly characterized botanical drug substance consisting of a complex oligomeric proanthocyanidin mixture derived from the latex of the Croton lechleri tree. Crofelemer is distinct from the raw traditional preparation and is the first and only oral botanical drug approved by the FDA. It was developed and approved as a delayed-release tablet through botanical identification, controlled sustainable harvesting, chemical characterization, biological testing, and clinical development."We are proud to be collaborating and interdependent with the people and tropical forest ecosystems of Peru. The world continues to learn that the conservation of tropical forests is often most effectively assured by the indigenous peoples who have been sustainably managing these ecosystems for centuries. They are dependent upon the water, air, animals, and plants of the forests for their physical and spiritual well-being, as is the rest of the world. They honor their relationship with the nurturing elements of their tropical forest homes. It is clear that the cultural and ecological health of people and forests are intertwined at multiple levels, and we wish to express our gratitude to these people and communities who have been working with and teaching members of our team for several decades how to sustainably manage this valuable medicinal plant within their ecosystems. They continue to integrate the Dragon's Blood tree, as Croton lechleri is referred to locally, into numerous creative reforestation strategies, as part of their sophisticated agroforestry and medicinal plant production systems," Dr. King added."Crofelemer represents a differentiated pharmaceutical development story: traditional medicinal knowledge helped identify a promising botanical source, and modern drug development transformed that knowledge into a highly characterized FDA-approved prescription drug under botanical guidance," said Lisa Conte, Jaguar's Founder, President, and CEO. "We believe Jaguar's experience with crofelemer - including sustainable harvesting, botanical CMC, mechanism-based bioassays, clinical development, and regulatory engagement, is directly relevant as we advance crofelemer for rare intestinal failure disorders such as microvillus inclusion disease and short bowel syndrome with intestinal failure. We also believe the specialized know-how required to develop and manufacture crofelemer represents a distinct competency for Jaguar."Jaguar's family company, Napo Pharmaceuticals, is developing a novel crofelemer powder for oral solution for rare and orphan gastrointestinal disorders involving intestinal failure, including MVID and SBS-IF. This investigational formulation is distinct from Mytesi®, the FDA-approved delayed-release tablet formulation of crofelemer indicated for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.MVID is an ultrarare congenital enteropathy with life-threatening dehydration beginning in infancy. Patients with MVID require life-sustaining and lifelong PS, including total parenteral nutrition (TPN) and supplemental intravenous fluids, to maintain hydration, electrolyte balance, nutrition, and support growth. In addition to MVID pathology, TPN is associated with significant co-morbidities. SBS-IF is a serious condition in which patients are unable to absorb sufficient fluids and nutrients through the intestine and also require life-sustaining PS for daily nutritional, electrolyte, and fluid requirements.Recent clinical, scientific, and regulatory milestones in crofelemer intestinal failure developmentJaguar has recently announced multiple milestones supporting the Company's crofelemer development strategy for intestinal failure:Clinical trial extension phase in MVID: Jaguar continues its pivotal trial in MVID with an extension phase for oral liquid crofelemer. The company has also announced active-treatment-only continuation of its pivotal multicenter clinical trial in pediatric patients with MVID to support a potential New Drug Application (NDA) for crofelemer powder for oral solution targeted for mid-2027.ESPGHAN late-breaking abstracts: Jaguar announced acceptance of two late-breaking abstracts for liquid oral crofelemer treatment of intestinal failure in pediatric patients at the 58th Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN). These include presentations related to pediatric intestinal failure patients receiving liquid oral crofelemer as an investigational drug under separate investigator-initiated and expanded access studies.Prior proof-of-concept results presented at NASPGHAN 2025: Jaguar previously announced initial proof-of-concept results showing that a liquid formulation of crofelemer reduced required TPN and/or supplementary intravenous fluids, collectively referred to as parenteral support (PS), in patients with intestinal failure due to MVID and SBS-IF of up to 37% in the first participating MVID patient and up to 15% in participating SBS-IF patientsBotanical drug CMC publication: A recent review article by Luo and Wu, "CMC Challenges and Solutions in Botanical IND & NDA Development - Lessons Learned from Four Approved Botanical Drugs," published in Botanical Drugs, discusses Mytesi/crofelemer as a key FDA-approved botanical drug case study. The article highlights the CMC and quality-control challenges associated with botanical drugs and describes how crofelemer required eco-geographic raw material controls, mechanism-relevant chloride-channel bioassays, and multi-batch clinical consistency evidence to support FDA approval. Crofelemer CMC complexity represents a potent barrier to generic or competitive replication."Crofelemer's complexity is not simply a scientific challenge - it is also a strategic differentiator. The modern development of crofelemer illustrates why botanical drug development requires specialized expertise," said Steven King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research, and Intellectual Property Officer. "Traditional medicinal use of Croton lechleri provided an important ethnobotanical starting point, yet crofelemer is a refined and highly characterized extract derived from Croton lechleri latex. Its development required research on sustainable harvesting, collaboration with multiple indigenous communities, conservation, pharmacology, quality control, manufacturing, and clinical research. This is the kind of long-term translational work that can connect traditional medicinal knowledge to modern drug development in a responsible and scientifically rigorous way."Crofelemer's first-in-class anti-secretory mechanism of action involves inhibitory modulation of intestinal chloride ion secretion through effects on two chloride ion channels in the intestinal membrane, including the cystic fibrosis transmembrane conductance regulator (CFTR) and calcium-activated chloride channels. This novel anti-secretory mechanism may be relevant to reducing the need for PS in rare intestinal failure disorders through reductions of excessive intestinal fluid loss and reduced needs for parenteral support."Biopharma investors and business development partners often focus on synthetic small molecules, biologics, gene therapies, and other familiar innovation categories," Conte added. "Crofelemer demonstrates another model of innovation: a botanical drug discovered through ethnobotanical research, developed through rigorous pharmaceutical standards, approved by FDA in one indication, and now being evaluated in genetically defined rare GI disorders with substantial unmet medical need. We believe this combination of scientific differentiation, regulatory precedent, CMC complexity, and rare disease development creates a compelling opportunity for patients in need and all Jaguar stakeholders."About CrofelemerCrofelemer is Jaguar's novel, oral, plant-based prescription drug derived from the latex of the Croton lechleri tree. Crofelemer is approved in tablet formulation by the U.S. FDA under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer is a first-in-class anti-secretory agent acting locally in the gastrointestinal tract.Jaguar family companies, Napo Pharmaceuticals, Inc., and Napo Therapeutics s.P.A. are developing crofelemer for multiple potential follow-on indications, with a novel powder for oral solution for rare intestinal failure (IF) disorders such as microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF), as well as other indications involving intestinal fluid loss.About Mytesi®
Mytesi® (crofelemer delayed-release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com.About Jaguar Health, Napo Pharmaceuticals, and Napo Therapeutics s.P.A.Jaguar Health, Inc. is a commercial-stage pharmaceutical company focused on developing novel, plant-based, sustainably derived prescription medicines for people and animals with gastrointestinal distress, including chronic, debilitating disorders. Jaguar's family companies, Napo Pharmaceuticals and Napo Therapeutics, focus on developing and commercializing proprietary human prescription pharmaceuticals for rare diseases from plants used traditionally in rainforest areas.For more information about Jaguar Health, please visit https://jaguar.health.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer may be developed for microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF); Jaguar's belief that crofelemer's mechanism of action may be relevant to serious rare disorders characterized by excessive intestinal fluid loss; Jaguar's expectations regarding the potential therapeutic utility of crofelemer in rare gastrointestinal disorders; Jaguar's plans to pursue development pathways for crofelemer in microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF); and Jaguar's belief that its ethnobotanical research, sustainable sourcing expertise, botanical CMC capabilities, and FDA botanical drug development experience represent differentiating capabilities.In some cases, forward-looking statements can be identified by terms such as "believe," "may," "will," "expects," "plans," "anticipates," "intends," "potential," "continue," "designed," or similar expressions. These statements involve substantial risks and uncertainties, including risks related to Jaguar's ability to successfully develop crofelemer for microvillus inclusion disease (MVID), short bowel syndrome with intestinal failure (SBS-IF), or other potential indications; the risk that clinical studies may not demonstrate safety or efficacy; the risk that regulatory authorities may not agree with Jaguar's proposed development or approval pathways; the risk that Jaguar may not be able to obtain or maintain regulatory approvals; the risk that Jaguar may not be able to secure sufficient financing, partnerships, or other resources to advance its development programs; and other risks described in Jaguar's filings with the Securities and Exchange Commission.Forward-looking statements speak only as of the date they are made. Jaguar undertakes no obligation to update any forward-looking statements, except as required by applicable law.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Research in Ethnobotanical Medicine Helps Advance Crofelemer Development for Genetically Defined Rare Congenital Gastrointestinal Disorders
US Market News
1月前
Jaguar Health Reports First Quarter 2026 FinancialsMay 20, 2026 4:40 PM
ACCESS NewswireNet revenue increased 816% in Q1 2026 vs. Q1 2025, and increased 527% in Q1 2026 vs. Q4 2025, buoyed by license of U.S. commercial rights for Mytesi® and Canalevia®-CA1Company continues its focus on crofelemer development efforts for rare-disease intestinal failure indications; two crofelemer presentations in pediatric intestinal failure patients with microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) to be made at 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in June 2026REMINDERS: Jaguar to host investor webcast Tuesday, May 26 at 8:30 a.m. Eastern regarding Q1 2026 financials and company updates (click here to register); Jaguar CEO Lisa Conte to present virtually on Thursday, May 28 at 10 a.m. Eastern at Lytham Partners Spring 2026 Investor Conference (click here to register)SAN FRANCISCO, CA / ACCESS Newswire / May 20, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated first-quarter 2026 financial results.2026 FIRST QUARTER COMPANY FINANCIAL RESULTS:License and Grant Revenue: Effective January 12, 2026, Jaguar entered a U.S. licensing agreement with Woodward Specialty, LLC ("Woodward"), an affiliate of privately held Future Pak, LLC ("Future Pak"). Under the terms of the agreement, Future Pak is now the exclusive U.S. marketer for the Company's Mytesi and Canalevia-CA1 products. License revenues for the $16 million initial payment, in addition to the $3.0 million payment for early termination of the Buy-Back Option under this agreement, were recognized by the Company in the first quarter of 2026. Per the terms of the agreement, an additional $2 million is due to Jaguar upon completion of post-closing conditions. Additionally, the Company recognized license fees of $42,500 in the first quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet. Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of March 31, 2026, the total deferred revenue associated with this contract amounts to $510,000. Federal grant revenue recognized in the first quarter of 2026 for the clinical study related to the treatment of chemotherapy-induced diarrhea ("CID") in dogs was $25,000 and none in 2025.Prescription Product Revenue, Net: The total net revenue for the Company's prescription products (Mytesi, Gelclair, and Canalevia-CA1) was approximately $1.2 million, of which approximately $174,000 stemmed from sales of Mytesi inventory in the first 11 days of the first quarter of 2026, with the remaining bulk of the $1.2 million net revenue stemming from sales of Mytesi inventory to Future Pak later in the first quarter of 2026. In January 2026, Jaguar entered into a royalty-free license agreement with Future Pak. Under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1, effective from January 12, 2026, are directed to Future Pak. This decision aligns with Jaguar's strategic focus on advancing the development of its powder-for-oral-solution formulation of crofelemer for rare-disease indications related to intestinal failure in humans. This represents a decrease of 62% compared to the fourth quarter of 2025, when total net revenue for prescription products was approximately $3.2 million. Additionally, prescription products net revenue decreased by 45% compared to the first quarter of 2025, when total revenues amounted to approximately $2.2 million.Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the first quarters of 2026 and 2025. Three Months Ending Financial Highlights March 31, (in thousands, except per share amounts) 2026 2025 $ change % change License and grant revenue, net $19,068 $43 19,025 44244%Product revenue, net 1,204 2,171 (967) -45%Total revenue, net $20,272 $2,214 18,058 816%Income (loss) from operations $10,182 $(9,421) 19,602 208%Net loss attributable to common stockholders $(7,015) $(10,464) 3,449 33%Net loss per share, basic and diluted $(13.60) $(584.45) 571 98%Cost of Product Revenue: The total cost of product revenue increased by $0.64 million, from $0.5 million for the quarter ended March 31, 2025 compared to about $1.2 million for the quarter ended March 31, 2026. The increase in cost was due to sales of inventory to Future Pak in the first quarter of 2026 under the licensing and supply agreement.Research and Development: The R&D expense increased by $0.2 million, from $3.7 million for the quarter ended March 31, 2025 compared to $3.9 million for the quarter ended March 31, 2026, primarily due to progress of the development of crofelemer into a powder formulation, a process called lyophilization.Sales and Marketing: The Sales and Marketing expense decreased by approximately $1.6 million, from $2.5 million for the quarter ended March 31, 2025 to approximately $0.9 million for the quarter ended March 31, 2026. The decrease was due to the dissolution of the Jaguar/Napo Sales and Marketing Group as of January 12, 2026 following the licensing of Mytesi and Canalevia-CA1 to Future Pak.General and Administrative: The G&A expense decreased by approximately $0.8 million, from $4.9 million in the quarter ended December 31, 2025 to $4.1 million in the quarter ended March 31, 2026, largely due to an overall decrease in legal and compliance fees, public company expenses, stock-based compensation and travel expenses.Income from Operations: Income from operations increased $19.6 million, from a loss of $9.4 million in the quarter ended March 31, 2025 to income of $10.2 million in the quarter ended March 31, 2026 largely from the license revenue recognized under the Future Pak agreement and decreased operating expenses.Net Loss: Net loss attributable to common shareholders decreased by approximately $3.4 million, from a loss of $10.5 million in the quarter ended March 31, 2025 to a loss of $7.1 million in the quarter ended March 31, 2026. In addition to the loss from operations:Interest expense increased by $0.8 million, from $56,000 for the quarter ended March 31, 2025 to approximately $0.7 million in the quarter ended March 31, 2026, due to interest expenses accrued on new notes.The fair value of financial and hybrid instrument designation at Fair Value Option ("FVO") decreased by $1.0 million, from a loss of $1.3 million in the quarter ended March 31, 2025 to a loss of $0.3 million in the quarter ended March 31, 2026, primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.Loss on extinguishment of debt was $0.6 million during the three months ended March 31, 2026 due to significant modifications that qualified for extinguishment accounting, with none recorded in the same period in 2025.Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for the first quarters of 2026 and 2025 were a net loss of $6.4 million and $9.7 million, respectively.
Three Months Ending
March 31, (in thousands) 2026 2025 $ change % change (unaudited) Net loss attributable to common stockholders $(7,015) $(10,464) 3,449 33%Adjustments: Interest expense 699 (56) 755 1349%Property and equipment depreciation 10 17 (7) -40%Amortization of intangible assets 463 463 (0) 0%Share-based compensation expense 155 301 (146) -48%
Non-GAAP EBITDA (5,688) (9,739) 4,051 -42%Loss on extinguishment of debt 628 - 628 100%Non-GAAP Recurring EBITDA $(5,060) $(9,739) 4,679 48%Note Regarding Use of Non-GAAP MeasuresThe Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition.About CrofelemerCrofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comAbout Mytesi®Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.About Gelclair®INDICATIONSGELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.IMPORTANT SAFETY INFORMATIONDo not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.If no improvement is seen within 7 days, a physician should be consulted.You are encouraged to report negative side effects of prescription medical products to the FDA.Visit www.fda.gov/safety/medwatch or call 1-855-273-0468.Please see full Prescribing Information at:https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdfImportant Safety Information About Canalevia®-CA1For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.See full Prescribing Information at Canalevia.com.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will hold an investor webcast on May 26, 2026, and Jaguar's expectation that Jaguar management will present at the Lytham Partners Spring 2026 Investor Conference. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Reports First Quarter 2026 Financials
US Market News
1月前
Jaguar Health to Hold Investor Webcast May 26 Regarding Q1 2026 Financials & Corporate Updates; Jaguar CEO Lisa Conte Presenting May 28 at Lytham Partners Spring 2026 Investor ConferenceMay 20, 2026 9:00 AM
ACCESS NewswireClick here to register for Jaguar's May 26 webcast; Click here to register for May 28 virtual presentation at Lytham Partners ConferenceCompany plans to file its Earnings Report on May 20, 2026 on Form 10-Q for the quarter ended March 31, 2026SAN FRANCISCO, CA / ACCESS Newswire / May 20, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the company will conduct an investor webcast on Tuesday, May 26, 2026 at 8:30 a.m. Eastern to review first-quarter 2026 financials and provide corporate updates, and that Lisa Conte, Jaguar's founder, president and CEO, will present virtually on Thursday, May 28, 2026 at 10 a.m. Eastern at the Lytham Partners Spring 2026 Investor Conference.Participation Instructions for Jaguar Health Investor Webcast
When: Tuesday, May 26, 2026 at 8:30 a.m. Eastern
Participant Registration & Access Link: Click Here
Replay: A replay of the webcast will be available on the investor relations section of Jaguar's website: (click here)Participation Instructions for Jaguar's Virtual Presentation at the Lytham Partners Spring 2026 Investor Conference
When: Thursday, May 28, 2026 at 10 a.m. Eastern
Registration link for conference: Click Here
Replay: A replay of the webcast will be available through the same link (click here)About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar will file its Form 10-Q on May 20, 2026 for the quarter ended March 31, 2026, the expectation that Jaguar will hold an investor webcast on May 26, 2026, and Jaguar's expectation that Jaguar management will present at the Lytham Partners Spring 2026 Investor Conference. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health to Hold Investor Webcast May 26 Regarding Q1 2026 Financials & Corporate Updates; Jaguar CEO Lisa Conte Presenting May 28 at Lytham Partners Spring 2026 Investor Conference
US Market News
1月前
Jaguar Health Announces Active Treatment Only Continuation of Pivotal Multicenter Clinical Trial in Pediatric Patients with Microvillus Inclusion Disease (MVID) to Support a New Drug Application (NDA) for Liquid Oral CrofelemerMay 19, 2026 9:00 AM
ACCESS NewswireFirst MVID patient enters the active treatment only extension phase after completion of randomized double-blind crossover period to evaluate longer-term safety and efficacy with liquid oral crofelemer as adjunctive treatment for MVID, an ultrarare pediatric disease with a lethal natural history and no approved therapies, requiring lifelong parenteral support (PS)SAN FRANCISCO, CA / ACCESS Newswire / May 19, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) announced that the first patient from the cohort of pediatric MVID patients in the pivotal MVID randomized double-blind crossover clinical trial has entered the active treatment only single-blind extension to evaluate the longer term safety and efficacy of crofelemer powder for oral solution as adjunctive treatment to parenteral support (PS) to support regulatory submissions for the drug to treat this serious unmet medical need. The trial is being conducted at multiple centers with appropriate regulatory approvals in the United States (US), European Union (EU), and United Arab Emirates (UAE).MVID is an ultrarare congenital enteropathy that causes intestinal failure (IF) from early childhood. Patients with MVID require lifelong and life-sustaining PS, consisting of total parenteral nutrition (TPN) with or without supplemental intravenous fluids, to provide the life-sustaining nutrients, electrolytes, and fluids for survival. Most MVID patients require daily PS, sometimes for 20 hours or more per day. While crucial for growth and survival for these patients, PS is associated with significant comorbidities, such as liver and kidney toxicities, metabolic complications, infections, and neurodevelopmental delays. There are currently no approved drug treatments for MVID. Incidence of MVID is extremely rare with a lethal natural history. The company estimates that oral liquid crofelemer treatment is being used as adjunctive therapy with PS in up to 4% of the prevalent global MVID patient population."In MVID, the therapeutic goal is to evaluate crofelemer's oral treatment to reduce the increased needs of PS to support growth, hydration, electrolytes, and nutritional requirements. This single-blind extension phase is an important clinical milestone for our pivotal randomized double-blind crossover clinical trial of crofelemer in the MVID trial to support the development and regulatory approval of the drug, intended to provide the longer-term safety and efficacy of crofelemer in MVID patients," said Dr. Pravin Chaturvedi, Chair of Scientific Advisory Board and Chief Scientific Officer of Napo Pharmaceuticals and Jaguar Health. "The decision to allow pediatric MVID patients to continue into the active treatment only single-blind extension phase after completion of the randomized double-blind crossover period is made by an independent data monitoring committee, which evaluates the safety data in a blinded setting.""This continuation of this pivotal clinical trial of crofelemer for treatment of MVID, which has a lethal natural history without life-sustaining parenteral support, and the burden on children and families is a key milestone for our development and regulatory submission plans," added Lisa Conte, President and CEO of Jaguar. "Our team continues to evaluate expedited regulatory pathways to support the approval of crofelemer as a potential first-in-class adjunctive therapy, if approved, to decrease PS requirements and improve the quality of lives of these MVID pediatric patients."As previously announced, Jaguar family company Napo plans to complete this pivotal, adequate and well-controlled clinical trial for the ultrarare pediatric MVID to support an NDA filing in mid-2027, subject to study completion and regulatory alignment. The Company will also include data from two additional MVID patients being evaluated under expanded access and open-label study protocols due to the ultrarare incidence and prevalence of MVID. Data from these two patients will be presented at the upcoming European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) annual meeting in June 2026. Jaguar has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for crofelemer for MVID treatment.Jaguar's MVID program is a part of the company's adult and pediatric intestinal failure (IF) development programs. In addition to MVID, the novel crofelemer powder for oral solution is also being evaluated in a blinded trial in adult patients with short bowel syndrome with IF (SBS-IF).About Crofelemer Powder for Oral SolutionCrofelemer powder for oral solution is a novel investigational oral formulation for treating the rare and orphan gastrointestinal disorders that cause intestinal failure, including MVID and SBS-IF. Crofelemer is a novel, plant-based antisecretory agent that acts locally in the gastrointestinal tract and helps normalize fluid and electrolyte balance by modulating chloride ion secretion. The formulation remains investigational and is currently not approved by FDA or EMA for MVID and SBS-IF.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel, proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Announces Active Treatment Only Continuation of Pivotal Multicenter Clinical Trial in Pediatric Patients with Microvillus Inclusion Disease (MVID) to Support a New Drug Application (NDA) for Liquid Oral Crofelemer
US Market News
1月前
Jaguar Health Regains Compliance with Nasdaq's Publicly Held Shares Requirement and Receives Additional Extension, Until May 18, 2026, to Demonstrate Compliance with Nasdaq's Bid Price RuleMay 8, 2026 9:00 AM
ACCESS NewswireSAN FRANCISCO, CA / ACCESS Newswire / May 8, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today provided an update on the status of the Company's listing on The Nasdaq Stock Market ("Nasdaq"). On May 6, 2026, Jaguar received a decision letter from the Nasdaq Hearings Panel ("Panel") granting the Company's request for an extension to demonstrate compliance with the Nasdaq Listing Rules.As previously disclosed, on May 1, 2026, Jaguar received written notification from the staff of the Listing Qualifications Department (the "Staff") of Nasdaq notifying the Company that Jaguar did not comply with the minimum 500,000 Publicly Held Shares requirement for continued inclusion set forth in Nasdaq Listing Rule 5550(a)(4) (the "Publicly Held Shares Requirement"). In addition, Staff noted that under Nasdaq Listing Rule 5810(c)(3)(A), the Company would remain non-compliant with both the minimum $1.00 bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule") and the Publicly Held Shares Requirement until the failure to meet the Publicly Held Shares Requirement is cured and, thereafter, the Company evidences a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, unless Staff exercises its discretion to extend the 10-day period as discussed in Nasdaq Listing Rule 5810(c)(3)(H).Following the exercise on May 4, 2026, by certain third-party investors of existing pre-funded warrants to purchase Common Stock, the Company regained compliance with the Publicly Held Shares Requirement.In its letter, the Panel stated that the Company's non-compliance with Listing Rule 5550(a)(4) reset the clock for the Company to regain compliance with the Bid Price Rule. Based upon the Company's representations, the Panel was willing to grant an additional one-day extension from May 15, 2026 to May 18, 2026 to the Company's deadline to demonstrate compliance with the Bid Price Rule by evidencing a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Regains Compliance with Nasdaq's Publicly Held Shares Requirement and Receives Additional Extension, Until May 18, 2026, to Demonstrate Compliance with Nasdaq's Bid Price Rule
US Market News
1月前
Jaguar Health Announces Preliminary Discussion with FDA to Evaluate Breakthrough Therapy Designation for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)May 6, 2026 9:00 AM
ACCESS NewswirePediatric patients with Intestinal Failure (IF) due to MVID, an ultrarare congenital disorder with lethal natural history, that has no available therapies and needs lifelong total Parenteral Support (PS), could benefit from expedited development of oral crofelemer via Breakthrough Therapy DesignationCrofelemer has demonstrated meaningful reductions in weekly PS needs in two pediatric MVID patients with initial results to be presented at ESPGHAN 2026SAN FRANCISCO, CA / ACCESS Newswire / May 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals Inc., announced that the Company recently held a preliminary discussion with the Division of Gastroenterology at U.S. Food and Drug Administration (FDA) to evaluate the possibility of a Breakthrough Therapy Designation (BTD) for oral liquid crofelemer as an adjunctive therapy to PS for the treatment of pediatric patients with intestinal failure (IF) due to microvillus inclusion disease (MVID), an ultrarare congenital disorder with a lethal natural history requiring lifelong PS. Crofelemer has demonstrated preliminary clinical proof of concept (POC) in pediatric MVID patients in two open-label studies, with meaningful reductions in weekly PS requirements for the two MVID patients. Initial results for long-term evidence of efficacy and safety from the open label studies in pediatric MVID patients have been accepted for presentations at the upcoming 58th Annual ESPGHAN (European Society for Paediatric Gastroenterology Hepatology and Nutrition) Meeting in June, 2026. Crofelemer is also being evaluated in a pivotal randomized double-blind placebo-controlled clinical study in pediatric MVID subjects which has completed enrollment in this ongoing adequate and well-controlled trial."We are pleased with the initial clinical POC results for the safety and effectiveness of liquid oral crofelemer as adjunctive therapy to life sustaining PS in pediatric IF patients. Our objective is to evaluate expedited pathways to support availability of crofelemer for the serious unmet need of IF in patients with MVID. There are no available therapies for MVID other than lifelong PS which is inadequate and associated with profound comorbidities. Breakthrough therapy designation in the US and PRIME in the European Union are important potential regulatory pathways to expedite access. To the best of our knowledge, crofelemer is being used to treat approximately 4% of the estimated living pediatric MVID patients. Crofelemer has demonstrated meaningful reductions in PS needs for pediatric IF patients with MVID. Crofelemer has been well tolerated, and the pediatric MVID patients are gaining weight and height and demonstrating reductions in their daily and weekly needs for PS. Since PS is associated with significant comorbidities, reductions in PS needs are expected to improve clinical outcomes as well as quality of life measures," said Dr. Pravin Chaturvedi, Napo's Chief Scientific Officer and Chair of the company's Scientific Advisory Board.Jaguar family company, Napo Pharmaceuticals, Inc., discussed the possibility of Breakthrough Therapy Designation for crofelemer for treatment of MVID as adjunctive therapy to lifelong PS with the FDA, given the preliminary clinical POC results in the open label studies. Breakthrough Therapy designation is an FDA program intended to expedite the development and review of drugs that are being developed to treat serious or life-threatening diseases or conditions where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.Jaguar and its family company Napo Pharmaceuticals have received orphan drug designations in the United States and European Union for crofelemer for both MVID and short bowel syndrome (SBS) with IF. The Company continues to advance its IF development programs, including ongoing work intended to support a potential future regulatory submission for crofelemer for MVID, subject to completion of the required clinical, regulatory, and manufacturing activities and further alignment with FDA."Engagement and regular communications with the FDA is a critical element of our effort to adopt the most efficient and expeditious pathway for crofelemer as a novel and first-in-class therapy for MVID as adjunctive therapy," Conte added. "We believe that oral crofelemer has the potential to modify the disease-progression of IF in MVID patients, and we intend to continue working with urgency to advance development and approval of crofelemer for this ultrarare pediatric patient population."About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure (IF), including MVID and Short Bowel Syndrome with IF (SBS-IF).For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements related to crofelemer receiving Breakthrough Designation for MVID from the FDA. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Announces Preliminary Discussion with FDA to Evaluate Breakthrough Therapy Designation for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)
US Market News
2月前
Jaguar Health Expands Neonorm Franchise with Introduction of Neonorm Dog for Companion Animal Gut HealthMay 4, 2026 8:30 AM
ACCESS NewswireNeonorm Dog extends Jaguar's existing Neonorm product franchise beyond foals and calves to provide dog owners with access to a plant-based product designed to support normal stool formation, gut hydration, and bowel healthExpansion builds on Jaguar's focus on sustainably derived, plant-based gastrointestinal products for people and animalsSAN FRANCISCO, CA / ACCESS Newswire / May 4, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced the planned launch of Neonorm Dog, a new extension of the Company's Neonorm franchise for companion animals. Neonorm Dog is designed to provide dog owners with access to a plant-based, non-prescription product intended to support normal stool formation, gut hydration, and bowel health in dogs. The Neonorm franchise currently includes Neonorm Foal and Neonorm Calf, plant-based products developed to support proper hydration and bowel health in pre-weaned foals and calves. Neonorm products contain a standardized botanical extract derived from the sustainably harvested Croton lechleri tree, act locally in the gut."We believe Neonorm Dog represents a natural and strategically important expansion of the Neonorm franchise," said Lisa Conte, Jaguar's founder, president, and CEO. "Dog owners are increasingly seeking products that are plant-based, non-antibiotic, and easy to incorporate into the management of digestive health. With Neonorm Dog, we expect to make the benefits of the Neonorm platform available to a much broader group of animals and pet owners."Jaguar's animal health strategy is focused on gastrointestinal products for companion and production animals. The Company's prescription animal health product Canalevia-CA1 is conditionally approved by FDA for the treatment of chemotherapy-induced diarrhea in dogs, and Jaguar recently announced statistically significant topline results from an effectiveness trial of crofelemer for treatment of chemotherapy-induced diarrhea in dogs, which the Company expects to support its advancement toward full FDA approval.The launch of Neonorm Dog is intended to broaden Jaguar's commercial footprint in the companion animal market and extend consumer awareness of the Neonorm brand. Dogs represent one of the largest companion animal populations in the United States and Europe, and Jaguar believes Neonorm Dog may create an opportunity to reach pet owners, veterinarians, and animal health retailers seeking non-antibiotic, plant-based options to support digestive health."Expanding Neonorm into dogs is consistent with Jaguar's broader commercial strategy: leverage our botanical gastrointestinal expertise across clearly defined markets where hydration, stool quality, and gut health matter," said Conte. "We believe Neonorm Dog has the potential to become an important addition to the Neonorm family and to increase awareness of Jaguar's animal health platform."Neonorm Dog is expected to be made available through select online and animal health retail channels as the company completes final packaging, labeling, and commercial launch preparations.About Neonorm
Neonorm is Jaguar's non-prescription animal-health franchise of plant-based products developed to support digestive health, hydration, and normal stool quality in animals. Existing Neonorm products include Neonorm Foal and Neonorm Calf. Neonorm Dog is not intended to diagnose, treat, cure, or prevent any disease and is not intended as a substitute for veterinary care.About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel, proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements related to Jaguar launching Neonorm Dog. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Expands Neonorm Franchise with Introduction of Neonorm Dog for Companion Animal Gut Health
US Market News
2月前
Jaguar Health Announces Statistically Significant Results from Effectiveness Trial of Crofelemer (FDA Approved Canalevia-CA1) for Treatment of Chemotherapy-Induced Diarrhea in DogsApril 29, 2026 8:30 AM
ACCESS NewswireCompany Advances Towards Full FDA Approval of Crofelemer for Chemotherapy-Induced DiarrheaSAN FRANCISCO, CA / ACCESS Newswire / April 29, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced topline results from the completion of its effectiveness trial of crofelemer (FDA conditionally approved Canalevia-CA1) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. The statistically significant results demonstrated that dogs suffering from CID that were treated with Canalevia-CA1 twice daily at the onset of diarrhea had, at the end of 3 days of treatment, an average daily stool that is regarded as normal. Moreover, an owner's survey at the end of the study reported that 83% of owners indicate that Canalevia-CA1 was an effective treatment for their dog's CID. Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog's CID. In comparison, only 12.5% of owners reported they saw an improvement in their dog's CID without the use of any chemotherapy-induced diarrhea treatments. The Company expects to file the data from the complete analysis of this trial in support of full regulatory approval of crofelemer for CID and also submit for scientific publication."We are quite pleased with the study results, supporting the paradigm shifting antisecretory mechanism of action of crofelemer in CID, typically a chloride ion mediated secretory diarrhea common across all mammals. Our vision at the company is to expand the opportunity to treat a broader collection of symptomatic diarrhea causes in companion animals with an anti-secretory approach," said Lisa Conte, Jaguar Founder and CEO.This study, "Clinical Field Study to Collect Real-World Data (RWD) to Demonstrate Real-World Evidence (RWE) of Effectiveness for Canalevia®-CA1 (Crofelemer delayed-release tablets) 125 mg for the Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs" is the pivotal study in substantiating treatment effectiveness in the upcoming Animal Drug application.Important Safety Information About Canalevia®-CA1For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Announces Statistically Significant Results from Effectiveness Trial of Crofelemer (FDA Approved Canalevia-CA1) for Treatment of Chemotherapy-Induced Diarrhea in Dogs
US Market News
2月前
Jaguar Health Granted Extension Until May 15, 2026, to Demonstrate Compliance with Nasdaq's Bid Price Rule; Company Announces Reverse Stock SplitApril 27, 2026 9:00 AM
ACCESS NewswireReverse split approved at April 2026 Special Meeting of StockholdersShares of Jaguar Health common stock to begin trading on split-adjusted basis on April 30, 2026SAN FRANCISCO, CA / ACCESS Newswire / April 27, 2026 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that on April 24, 2026, the Company received formal notice that the Nasdaq Hearings Panel (the "Panel") has granted Jaguar an extension through May 15, 2026, to demonstrate compliance with the $1.00 bid price rule for continued listing on The Nasdaq Capital Market. To evidence compliance, the Company must report a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days on or before May 15, 2026. The Panel may defer a compliance determination for up to 20 business days.To support compliance with the $1.00 bid price rule, Jaguar today announced that it will effect a reverse stock split of its issued and outstanding voting common stock ("Common Stock"), at an exchange ratio of 1-for-35, on Thursday, April 30, 2026, (the "Effective Date"). The Company's Common Stock will begin trading on a split-adjusted basis when the market opens on the Effective Date and will remain listed on The Nasdaq Capital Market under the symbol "JAGX." The new CUSIP number for the Company's Common Stock following the reverse stock split is 47010C862.The effectuation of the reverse stock split follows the approval of a proposal submitted to Jaguar stockholders at a Special Meeting of Stockholders (the "Special Meeting"). This proposal is described in detail in the Company's definitive proxy statement on Schedule 14A relating to the Special Meeting filed with the Securities and Exchange Commission (the "SEC") on March 24, 2026. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company's corporate website.When the reverse stock split becomes effective, every thirty-five (35) shares of the Company's Common Stock immediately prior to the Effective Date shall automatically be reclassified into one (1) share of Common Stock, without any change in the par value per share, and this change will be reflected on Nasdaq's website and other stock quote platforms. No fractional shares will be issued as a result of the reverse stock split. Stockholders who otherwise would be entitled to receive a fractional share in connection with the reverse stock split will receive a cash payment in lieu thereof.Equiniti Trust Company, LLC is acting as exchange agent for the reverse stock split and will send instructions to stockholders of record who hold stock certificates regarding the exchange of their certificates for post-reverse stock split shares of Common Stock. Stockholders who hold their shares in brokerage accounts or "street name" are not required to take any action to effect the exchange of their shares.About the Jaguar Health Family of Companies
Jaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.comForward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the Company's Common Stock will begin trading on a split-adjusted basis when the market opens on the Effective Date. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:
hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Granted Extension Until May 15, 2026, to Demonstrate Compliance with Nasdaq's Bid Price Rule; Company Announces Reverse Stock Split
US Market News
2月前
Jaguar Health Reports Approval of All Proposals at April 2026 Special Meeting of StockholdersApril 20, 2026 4:15 PM
ACCESS NewswireSAN FRANCISCO, CA / ACCESS Newswire / April 20, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Special Meeting of Stockholders held on April 20, 2026 (the "Special Meeting").Five proposals were submitted to and approved by the stockholders of the Company at the Special Meeting. The proposals are described in detail in the Company's definitive proxy statement on Schedule 14A relating to the Special Meeting filed with the Securities and Exchange Commission on March 24, 2026. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company's corporate website.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.healthJaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Reports Approval of All Proposals at April 2026 Special Meeting of Stockholders
US Market News
2月前
Reminder: Jaguar Health to Host Investor Webcast at 8:30 am Eastern on Friday, April 10, 2026 Regarding Q4 2025 Financials and Company UpdatesApril 9, 2026 8:15 PM
ACCESS NewswireClick here to registerSAN FRANCISCO, CA / ACCESS Newswire / April 9, 2026 / Jaguar Health, Inc.(NASDAQ:JAGX)Participation Instructions for WebcastWhen: Friday, April 10, 2026 at 8:30 a.m. EasternParticipant Registration & Access Link: Click HereReplay Instructions for WebcastReplay of the webcast on the investor relations section of Jaguar's website: (click here)About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will hold an investor webcast on April 1, 2026. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Reminder: Jaguar Health to Host Investor Webcast at 8:30 am Eastern on Friday, April 10, 2026 Regarding Q4 2025 Financials and Company Updates
US Market News
2月前
Jaguar Health Reports 2025 FinancialsApril 7, 2026 8:30 AM
ACCESS NewswireNet revenue increase of 5% in Q4 2025 vs. Q3 2025Jaguar received an up-front payment of $16Mof non-dilutive capital in January 2026 upon entering U.S. license agreement with Future Pak for Mytesi® and Canalevia®-CA1 - Jaguar's commercialized crofelemer drugs - with an additional $2 million due upon completion of post-closing conditions; and has received $3.0 of up to $20 million in milestone payments and other future paymentsAgreement with Future Pak is fully aligned with Jaguar's strategy to concentrate crofelemer development efforts on human rare-disease intestinal failure indications moving forwardJaguar will appeal Nasdaq's March 5, 2026 noncompliance determination related to Nasdaq Listing Rule 5550(a)(2) at a hearing on April 7, 2026; delisting is stayed pending the panel's final decisionREMINDER: Friday, April 10, Jaguar to host investor webcast at 8:30 a.m. Eastern regarding Q4 2025 financials and company updates; Click here to registerSAN FRANCISCO, CA / ACCESS Newswire / April 7, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated fourth-quarter 2025 financial results.2025 FOURTH QUARTER COMPANY FINANCIAL RESULTS:Net Revenue: The total net revenue for the Company's prescription products (Mytesi®, Gelclair®, and Canalevia®-CA1), non-prescription products, and license revenue was approximately $3.2 million in the fourth quarter of 2025, representing an increase of 5% over the total net revenue in the third quarter of 2025, which totaled approximately $3.1 million, and a decrease of approximately 8% over the total net revenue in the fourth quarter of 2024, which totaled approximately $3.5 million.In 2025, approximately $11.2 million out of the Company's total net revenue of $11.5 million was generated by sales of Mytesi and Canalevia-CA1. Under the terms of the license agreement Jaguar entered with Future Pak ("FP") in January 2026, FP will be responsible for all commercial efforts, and will receive all proceeds from the U.S. sales of Mytesi and Canalevia-CA1 as of January 12, 2026. Jaguar will be responsible for supply of product at a premium price and will recognize manufacturing revenue. FP has already purchased product from Jaguar, in addition to $16.0 mm of the up-front license fee and other $3.0 mm payment. The license agreement is in alignment with Jaguar's strategy to concentrate on crofelemer late-stage development efforts for human rare-disease intestinal failure indications.Mytesi Prescription Volume: Mytesi prescription volume decreased approximately 3.7% in the year 2025 over 2024, by approximately 5.8% in the fourth quarter of 2025 over the third quarter of 2025, and by approximately 12.2% in the fourth quarter of 2025 over the fourth quarter of 2024. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.License Revenue: For the fourth quarter of 2025, the Company recognized license fees of $42,500 from a securities purchase agreement with a European partner. As of December 31, 2025, the total deferred revenue associated with this contract amounts to approximately $552,000.Neonorm™: Revenues for the non-prescription Neonorm products were minimal for the fourth quarters of 2025 and 2024.Cost of Product Revenue: Total cost of product revenue increased by $1.8 million, from $2.0 million for the year ended December 31, 2024 compared to about $3.8 million for the year ended December 31, 2025, due largely from a $2.0 million reserve related to adjusting inventory to its fair value at December 31, 2025.Research and Development: The R&D expense increased by $8.4 million, from $16.5 million for the year ended December 31, 2024 compared to approximately $25.0 million in 2025, primarily due to the clinical and manufacturing expenses associated with crofelemer lyophilization and clinical trial data charged to expenses, as they have no alternative future use. The remaining increase was attributable to the continued advancement of our clinical programs into later-stage development, resulting in higher clinical trial-related expenses and expanded contract manufacturing activities.Sales and Marketing: The Sales and Marketing expense increased by approximately $1.5 million, from $7.7 million for the year ended December 31, 2024 to approximately $9.2 million for the year ended December 31, 2025 largely due to personnel and related benefits related to the Gelclair sales team.General and Administrative: The G&A expense increased by approximately $2.3 million, from $16.3 million for the year ended December 31, 2024 to $18.6 million in 2025, largely due to increased legal and compliance expenses from Mytesi & Canalevia licensing to Woodward Specialty LLC, printing costs, investor relations, and financing activities.Impairment loss on indefinite-lived intangible assets: The Company recognized an impairment loss on intangible assets amounting to $0.8 million as a result of impairment evaluation to its in-process research and development ("IPR&D") triggered by delays in IBS and PEDS programs, resulting in a decline of the estimated fair values of IPR&D. There was no impairment loss recognized in 2024.Loss from Operations: Loss from operations increased by $15.1 million, from $30.8 million in the year ended December 31, 2024 to $45.9 million in 2025.Net Loss: Net loss attributable to common shareholders increased by approximately $15.1 million, from $38.5 million in the year ended December 31, 2024 to $53.6 million in 2025. In addition to the loss from operations:The fair value of financial and hybrid instrument designation at Fair Value Option ("FVO") decreased by $3.2 million, from a loss of $9.5 million in the year ended December 31, 2024, to a loss of $6.3 million in 2025, primarily due to fair value adjustments in notes payable designated at FVO.Loss on extinguishment of debt increased by $3.0 million from a gain of $1.2 million in the year ended December 31, 2024 to a loss of $1.8 million in 2025, primarily due to substantial modifications to the expected payments of one royalty interest agreement, which triggered extinguishment accounting. Year Ended Financial Highlights December 31, (in thousands, except per share amounts) 2025 2024 $ change % change Net product revenue $11,511 $11,689 (178) -1.5%Loss from operations $(45,908) $(30,831) (15,077) 32.8%Net loss attributable to common stockholders $(53,575) $(38,492) (15,083) 28.2%Net loss per share, basic and diluted $(24.27) $(130.69) 106 Non-GAAP Recurring EBITDA: Non-GAAP recurring EBITDA for 2025 and 2024 were a net loss of $48.1 million and $35.9 million, respectively. Year Ended December 31, (in thousands) 2025 2024 $ change % change (unaudited) Net loss attributable to common stockholders $(53,575)
$(38,492)
15,083 -39%Adjustments: Interest income (expense) 67 231 164 71%Property and equipment depreciation 62 67 5 7%Amortization of intangible assets 1,851 1,834 (17) -1%Share-based compensation expense 835 1,641 806 49%Gain (loss) on extinguishment of debt 1,799 (1,245) (3,044) 244%Impairment loss on indefinite-lived intangible assets 800 - 800 100%Non-GAAP EBITDA (48,161) (35,964) 12,197 -34% Note Regarding Use of Non-GAAP MeasuresThe Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar's performance and provide useful information to investors regarding the Company's results of operations and financial condition.Participation Instructions for WebcastWhen: Friday, April 10, 2026 at 8:30 a.m. EasternParticipant Registration & Access Link: Click HereReplay Instructions for WebcastReplay of the webcast on the investor relations section of Jaguar's website: (click here)About CrofelemerCrofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp, is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comAbout Mytesi®Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.About Gelclair®INDICATIONSGELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.IMPORTANT SAFETY INFORMATIONDo not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.If no improvement is seen within 7 days, a physician should be consulted.You are encouraged to report negative side effects of prescription medical products to the FDA.Visit www.fda.gov/safety/medwatch or call 1-855-273-0468.Please see full Prescribing Information at:https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdfImportant Safety Information About Canalevia®-CA1For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling.Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.See full Prescribing Information at Canalevia.com.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will have a hearing on April 7, 2026 with the Nasdaq Hearings Department, and Jaguar's expectation that it will hold an investor webcast on April 10, 2026. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Reports 2025 Financials
US Market News
3月前
FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)March 18, 2026 9:00 AM
ACCESS NewswireMVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with significant toxicities; PS reduction could potentially reduce co-morbidities and improve clinical benefit, as no approved therapies exist for MVIDJaguar launches news alert text service for investors - click here to sign up for text alertsSAN FRANCISCO, CA / ACCESS Newswire / March 18, 2026 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support (PS) requirements, which may result in disease progression-modification of MVID."We are pleased to have the opportunity to continue treatment with crofelemer powder for oral solution in our ongoing clinical trial of crofelemer in pediatric MVID patients," said Pravin Chaturvedi, PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board. "This would allow patients who have completed their double-blind treatment period to be eligible for the single-blind phase of continued treatment with crofelemer for further assessment of clinical benefit through reduction of PS for a longer period. PS reduction could potentially reduce co-morbidities associated with the disease and TPN; thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID."The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee (DMC), which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately 30% of the participating MVID patients have completed the study's double-blind treatment phase and the clinical investigators are supporting the patients' participation in the single-blind extended phase.This trial of crofelemer in MVID patients has clinical sites in the US, Italy and the UAE, and the consent from the FDA, the European Medicines Agency (EMA), The Ministry of Health and Prevention (MOHAP), and the Institutional Review Boards (IRBs) for each site."Our development plan for this ultrarare disease, with an expected improved clinical benefit from the longer treatment in the extension phase, may also support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval for this ultrarare pediatric disorder," said Lisa Conte, Jaguar's founder, president, and CEO. "The extremely low incidence and prevalence of MVID, its lethal natural history and the fact that no therapies are available for MVID other than lifelong PS, underscores the need for new therapies. Together with the support of MVID clinical key opinion leaders (KOLs), we are exploring expedited regulatory pathways for crofelemer."About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Napo will initiate a single-blind extension phase for its MVID trial, the expectation that PS reduction could potentially reduce co-morbidities associated with MVID and TPN, thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID, and Jaguar's expectation that its development plan for MVID may support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)
US Market News
3月前
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, Initiates Preclinical Study of Coca for Appetite SuppressionMarch 16, 2026 9:00 AM
ACCESS NewswireWhole leaf coca extract under evaluation is Magdalena's drug candidate for post-GLP-1 weight loss managementSAN FRANCISCO, CA / ACCESS Newswire / March 16, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Magdalena Biosciences ("Magdalena"), a US-based joint venture formed by Jaguar and Canada-based Filament Health Corp. (OTC:FLHLF) ("Filament"), has initiated a preclinical study evaluating the effectiveness of a whole leaf coca extract for appetite suppression. The coca leaf extract is Magdalena's drug candidate for post-GLP-1 weight loss management. This one-month study in mice is being conducted in Alberta, Canada."We are very pleased to have initiated this study of Magdalena's whole leaf coca extract being developed under FDA botanical drug guidance," said Steven King, Ph.D., Jaguar's Chief Sustainable Supply and Ethnobotanical Research Officer and an Advisor to Magdalena. "Indigenous peoples and healers in the Andean region of Peru have utilized coca for centuries to manage hunger and fatigue. Magdalena is focusing on a number of potential applications for a coca-based therapeutic that can help suppress appetite, including but not limited to appetite suppression in people who have taken GLP-1's and related drugs on a short-term basis and who are eager to not add weight back following treatment. It's common for people to regain weight after stopping GLP-1 drugs because these medications actively change appetite and metabolism while you take them. When the drug is removed, the body's natural weight-regulation system often returns to its previous state."The coca leaf that is part of this Magdalena research and development program was provided to Magdalena by Empresa Nacional de La Coca (ENACO), a Peruvian state company dedicated to the commercialization of the coca leaf and derivatives, with an Internationally Recognized Certificate of Compliance (IRCC) in compliance with the Nagoya Protocol requirements of Peru.As announced, Magdalena also plans to evaluate a variety of potential mental health and central nervous system (CNS) indications for coca, including attention-deficit/hyperactivity disorder (ADHD) and other neuropsychiatric indications."We believe the development of FDA-approved drugs from ‘whole extract' coca leaf can provide therapeutic benefit, and that the development process will benefit the people of Peru, who have been sustainably producing coca leaves for several thousand years. Plant-derived medicines offer potential new mechanisms of action while being potentially safer than chemically synthesized small molecule drugs that may have ‘off target' effects," Dr. King said. "We are grateful to the people of the Andean region who have domesticated the sacred plant, ‘mama coca,' which is and has been interwoven in the ritual, spiritual and traditional medicine of indigenous and non-indigenous communities for an estimated 8,000 years."Image of coca leaves. © Steven King, Ph.D. "The initiation of this study in Alberta is a key step in the important work of exploring coca leaf's therapeutic potential for appetite suppression and weight loss management," said Lisa Conte, Jaguar's founder, president, and CEO and a member of Magdalena's board of directors.ABOUT MAGDALENA BIOSCIENCESJaguar Health, Inc. and Filament Health Corp. formed Magdalena Biosciences, Inc. as a joint venture in 2023 to develop novel, natural prescription medicines derived from plants for mental health and CNS indications. Boulder, Colorado-based One Small Planet, founded by Will Peterffy, has committed to funding of US$1,000,000. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders.ABOUT FILAMENT HEALTH (OTC:FLHLF)Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates.Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.About the Jaguar Health Family of CompaniesJaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Magdalena will evaluate a variety of potential mental health and CNS indications for coca, including ADHD and other neuropsychiatric indications, the expectation that development of drugs from ‘whole extract' coca leaf can provide therapeutic benefit and that the development process will benefit the people of Peru. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact Info:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, Initiates Preclinical Study of Coca for Appetite Suppression
US Market News
3月前
Jaguar Health Strengthens Company's Balance Sheet by Restructuring and Reducing Royalty and Debt Obligations and Extinguishing WarrantsMarch 9, 2026 9:00 AM
ACCESS NewswireStrengthening balance sheet and capitalization is a key Jaguar priorityCompany continues its sharp, strategic focus on global development program for crofelemer for rare-disease intestinal failure indicationsSAN FRANCISCO, CA / ACCESS Newswire / March 9, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or "the Company") today announced that the Company has strengthened its balance sheet by restructuring and reducing its royalty obligations and debt held by affiliates of Chicago Venture Partners L.P., including the extinguishment of 48,212 warrants. The restructuring consisted of an initial reduction of approximately 10% (amounting to a reduction of approximately $3 million) of royalty obligations and debt; extending the maturity date by three years for a secured revolving line of credit for approximately $7 million put in place in November 2025; and ensuring that there are no maturity dates before July 2026 for any debt held by affiliates of Chicago Venture Partners L.P."We are very pleased to have completed this debt restructuring, and we plan to pursue additional potential opportunities to further restructure and reduce debt over the coming months in agreement with the debt holder," said Lisa Conte, Jaguar's founder, president, and CEO. "Strengthening Jaguar's balance sheet and capitalization is a key priority. Operationally, we continue to sharply focus on our ongoing global development program for our crofelemer powder-for-oral-solution formulation for rare-disease intestinal failure indications. Our intestinal failure program is expected to continue to provide clinical proof-of-concept milestones and is the subject of business development discussions with the potential to bring in non-dilutive funds from potential licensee partners."About CrofelemerCrofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will pursue additional potential opportunities to further restructure and reduce debt over the coming months, Jaguar's expectation that its intestinal failure program will continue to provide clinical proof-of-concept milestones, and Jaguar's expectation that the opportunity may exist to bring in non-dilutive funds from potential licensee partners to support the intestinal failure program. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Strengthens Company's Balance Sheet by Restructuring and Reducing Royalty and Debt Obligations and Extinguishing Warrants
US Market News
4月前
Reminder: Today, March 2, 2026, is the Record Date for Jaguar Health's Special One-time Stock DividendMarch 2, 2026 9:00 AM
ACCESS NewswireDividend intended to provide dilution protection to Jaguar shareholders as company explores pathway to restructure debtSAN FRANCISCO, CALIFORNIA / ACCESS Newswire / March 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or "the Company") today issued a reminder that today, March 2, 2026, is the Record Date for the Company's one-time special stock dividend (the "Special Stock Dividend"). As announced, in February 2026 Jaguar's Board of Directors declared a one-time Special Stock Dividend to holders of Jaguar Common Stock and certain outstanding warrants as of record on March 2, 2026. The Special Stock Dividend will consist of the Company's Series O Convertible Preferred Stock (the "Preferred Stock").The payment date for the Special Stock Dividend is March 4, 2026, two days after the Record Date. The dividend will be sent to eligible holders of Jaguar Common Stock and certain outstanding warrants automatically, with no action required by the eligible parties."Jaguar is issuing the Special Stock Dividend to reward and recognize our passionate and supportive stockholders and provide protection against potential dilution as we explore pathways to repay and restructure our existing indebtedness," said Lisa Conte, Jaguar's founder, president, and CEO. "Jaguar has a sharp strategic focus on our ongoing global development program for our crofelemer powder-for-oral-solution formulation for intestinal failure. As announced, Jaguar was provided with meaningful non-dilutive capital in January 2026 upon entering a U.S. license agreement with Future Pak for Mytesi® - an agreement that is fully aligned with our strategy to concentrate Jaguar's crofelemer development efforts on human rare-disease intestinal failure indications."The Preferred Stock is not transferable and will not be listed for trading on any stock exchange and will not trade with the Common Stock. For additional information about the Special Stock Dividend and terms of the Preferred Stock and associated risk factors, please refer to the Form 8-K the Company filed with the U.S. Securities and Exchange Commission on February 18, 2026, which can be viewed on the Company's website by clicking here.About CrofelemerCrofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding payment of dividends. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:hello@jaguar.healthJaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Reminder: Today, March 2, 2026, is the Record Date for Jaguar Health's Special One-time Stock Dividend
US Market News
4月前
Jaguar Health Announces a Special One-time Stock DividendFebruary 18, 2026 9:00 AM
ACCESS NewswireDividend intended to provide dilution protection to Jaguar shareholders as company explores pathway to restructure debtSAN FRANCISCO, CA / ACCESS Newswire / February 18, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or "the Company") today announced that its Board of Directors has declared a one-time special stock dividend (the "Special Stock Dividend") to holders of Jaguar Common Stock and certain outstanding warrants as of record on March 2, 2026. The Special Stock Dividend will consist of the Company's Series O Convertible Preferred Stock (the "Preferred Stock").Only persons who own shares of the Company's voting common stock (the "Common Stock"), or certain warrants to purchase Common Stock with dividend rights (the "Warrants") at the close of business on March 2, 2026 (the "Record Date") will be entitled to receive shares of the Preferred Stock. Each share of Preferred Stock will convert into shares of Common Stock at the Company's election at any time as determined by the Board of Directors, provided, however, if the Preferred Stock has not converted by December 31, 2026, the Preferred Stock will automatically convert on that date. The conversion will be at a value based on the market price of the Common Stock at the time of conversion. The Board of Directors of the Company may elect to have the Preferred Stock converted into Common Stock based on several factors, including the potential reduction of debt in the Company and how that might affect risk of future dilution after conversion of the Preferred Stock into Common Stock."Jaguar is issuing the Special Stock Dividend to reward and recognize our passionate and supportive stockholders and provide protection against potential dilution as we explore pathways to repay and restructure our existing indebtedness," said Lisa Conte, Jaguar's founder, president, and CEO. "Jaguar has a sharp strategic focus on our ongoing global development program for our crofelemer powder-for-oral-solution formulation for intestinal failure. As announced, Jaguar was provided with meaningful non-dilutive capital in January 2026 upon entering a U.S. license agreement with Future Pak for Mytesi® - an agreement that is fully aligned with our strategy to concentrate Jaguar's crofelemer development efforts on human rare-disease intestinal failure indications. Our intestinal failure program is expected to continue to provide clinical proof-of-concept milestones and is the subject of business development discussions with the potential to bring in non-dilutive funds from potential licensee partners. Jaguar is targeting Breakthrough Therapy designation for crofelemer for the indication of microvillus inclusion disease (MVID), with a planned filing of an NDA (New Drug Application) with the U.S. Food and Drug Administration for this indication in the first half of 2027. MVID is a lethal and ultrarare genetic pediatric disorder that causes intestinal failure. Crofelemer recently demonstrated groundbreaking benefit in the initial pediatric MVID patient treated - demonstrating a reduction in weekly parenteral support (PS) needs of up to 37%. The safety of locally acting crofelemer continues to be a hallmark of the drug and a critical factor in assessing the benefit-to-risk ratio of crofelemer for intestinal failure patients. Our crofelemer intestinal failure programs are also enhanced by clinical proof-of-concept data in pediatric patients with intestinal failure due to its effects in another rare disease, short bowel syndrome with intestinal failure (SBS-IF). The Company has an ongoing randomized double-blind placebo-controlled Phase 2 study of crofelemer powder-for-oral solution in adult SBS-IF patients."The payment date for the Special Stock Dividend is March 4, 2026, two days after the Record Date. The Preferred Stock is not transferable and will not be listed for trading on any stock exchange and will not trade with the Common Stock.Distribution of the Special Stock Dividend is a special one-time event. The payment of dividends in the future is subject to the discretion of the Board of Directors, which will evaluate the possibility of future dividend distributions from time to time based on factors that the Board of Directors deem relevant. However, no additional dividends have been authorized or are being contemplated at this time.For additional information about the Special Stock Dividend and terms of the Preferred Stock and associated risk factors, please refer to the Form 8-K the Company filed with the U.S. Securities and Exchange Commission on February 18, 2026, which can be viewed on the Company's website by clicking here.About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit napopharma.comNapo Therapeutics, visit napotherapeutics.comForward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding payment of dividends, conversion of the Preferred Stock, Jaguar's expectation that its intestinal failure program will continue to provide clinical proof-of-concept milestones, Jaguar's expectation that the opportunity may exist to bring in non-dilutive funds from potential licensee partners to support the intestinal failure program, Jaguar's plans to pursue Breakthrough Therapy designation for crofelemer for the indication of MVID, and Jaguar's expectation that the Company will file an NDA with the U.S. Food and Drug Administration for the MVID indication in the first half of 2027. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:
hello@jaguar.health
Jaguar-JAGXSOURCE: Jaguar Health, Inc.View the original press release on ACCESS NewswireOriginal: Jaguar Health Announces a Special One-time Stock Dividend