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Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders

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Jaguar Health (NASDAQ:JAGX) announced the approval of all seven proposals at its August 2025 Annual Meeting of Stockholders. The company highlighted key clinical developments, including proof-of-concept results showing crofelemer reduced total parenteral nutrition by up to 27% in MVID patients and 12.5% in SBS-IF patients in an Abu Dhabi trial.

Following an FDA meeting, Jaguar outlined its regulatory pathway for a supplemental NDA for crofelemer in metastatic breast cancer patients. The company's strategy focuses on seeking business development partnerships for orphan indication products to secure non-dilutive funding.

Jaguar Health (NASDAQ:JAGX) ha comunicato l'approvazione di tutte e sette le proposte presentate all'Assemblea annuale degli azionisti di agosto 2025. La società ha messo in evidenza sviluppi clinici rilevanti, tra cui i risultati di proof-of-concept che mostrano come la crofelemer abbia ridotto la nutrizione parenterale totale fino al 27% nei pazienti con MVID e al 12,5% nei pazienti con SBS-IF in uno studio condotto ad Abu Dhabi.

In seguito a un incontro con la FDA, Jaguar ha delineato il percorso regolatorio per una NDA supplementare della crofelemer nei pazienti con carcinoma mammario metastatico. La strategia aziendale punta a ricercare partnership di sviluppo commerciale per i prodotti con indicazioni orfane, al fine di assicurare finanziamenti non diluitivi.

Jaguar Health (NASDAQ:JAGX) anunció la aprobación de las siete propuestas en su Junta Anual de Accionistas de agosto de 2025. La compañía destacó desarrollos clínicos clave, incluidos los resultados de prueba de concepto que muestran que la crofelemer redujo la nutrición parenteral total hasta un 27% en pacientes con MVID y un 12,5% en pacientes con SBS-IF en un ensayo realizado en Abu Dabi.

Tras una reunión con la FDA, Jaguar describió la vía regulatoria para una NDA suplementaria de crofelemer en pacientes con cáncer de mama metastásico. La estrategia de la compañía se centra en buscar alianzas de desarrollo comercial para productos con indicaciones huérfanas, con el objetivo de obtener financiación no dilutiva.

Jaguar Health (NASDAQ:JAGX)는 2025년 8월 주주총회에서 제출된 7개 안건 모두가 승인되었다고 발표했습니다. 회사는 임상적으로 중요한 진전을 강조했으며, 아부다비 임상에서 개념증명(proof-of-concept) 결과로 크로펠머가 MVID 환자의 총 비경구 영양을 최대 27%, SBS-IF 환자에서는 12.5%까지 감소시켰음을 보고했습니다.

FDA와의 회의 후 Jaguar는 전이성 유방암 환자를 대상으로 한 크로펠머의 보충 NDA에 대한 규제 경로를 제시했습니다. 회사의 전략은 희귀질환 적응증 제품에 대해 사업 개발 파트너십을 모색하여 비희석성 자금을 확보하는 데 중점을 두고 있습니다.

Jaguar Health (NASDAQ:JAGX) a annoncé l'approbation des sept propositions lors de son assemblée générale annuelle d'août 2025. La société a souligné des avancées cliniques clés, notamment des résultats de preuve de concept montrant que la crofelemer a réduit la nutrition parentérale totale jusqu'à 27 % chez les patients MVID et 12,5 % chez les patients SBS-IF dans un essai mené à Abu Dhabi.

À la suite d'une réunion avec la FDA, Jaguar a présenté sa trajectoire réglementaire pour un NDA supplémentaire concernant la crofelemer chez les patientes atteintes de cancer du sein métastatique. La stratégie de l'entreprise consiste à rechercher des partenariats de développement commercial pour des produits à indication orpheline afin d'obtenir des financements non dilutifs.

Jaguar Health (NASDAQ:JAGX) gab bekannt, dass auf der Hauptversammlung im August 2025 alle sieben Anträge genehmigt wurden. Das Unternehmen hob wichtige klinische Entwicklungen hervor, darunter Proof-of-Concept-Ergebnisse, die zeigten, dass Crofelemer die totale parenterale Ernährung in einer Studie in Abu Dhabi um bis zu 27 % bei MVID-Patienten und um 12,5 % bei SBS-IF-Patienten reduzierte.

Nach einem Treffen mit der FDA skizzierte Jaguar den regulatorischen Weg für eine ergänzende NDA für Crofelemer bei Patientinnen mit metastasiertem Brustkrebs. Die Unternehmensstrategie zielt darauf ab, für Produkte mit Orphan-Indikationen Geschäfts­entwicklungs­partnerschaften zu finden, um nicht verwässernde Finanzierungen zu sichern.

Positive
  • Positive clinical results showing up to 27% reduction in parenteral nutrition for MVID patients
  • FDA pathway established for supplemental NDA in metastatic breast cancer indication
  • Strategy focused on non-dilutive funding through business development partnerships
Negative
  • Relatively modest 12.5% reduction in parenteral nutrition for SBS-IF patients
  • Company appears to be seeking partnerships, suggesting potential capital needs

Jaguar CEO Lisa Conte presenting August 20 at Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome (SBS-IF) patient by up to 12.5%; FDA meeting resulted in planned Jaguar regulatory pathway to complete supplemental NDA strategy for crofelemer for patients with metastatic breast cancer, a population meeting orphan definition in US

Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's orphan indication products, resulting in non-dilutive funding for Jaguar

SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Annual Meeting of Stockholders held on August 19, 2025 (the "Annual Meeting").

Seven 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 and supplemental information filed with the Securities and Exchange Commission on July 21, 2025 and as amended on August 6, 2025. 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 Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. 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 www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the August 2025 Emerging Growth Conference, and statements regarding Jaguar's planned regulatory pathway to complete a supplemental NDA for crofelemer for patients with metastatic breast cancer. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.



View the original press release on ACCESS Newswire

FAQ

What were the key voting results at Jaguar Health's August 2025 Annual Meeting?

All seven proposals submitted to stockholders at Jaguar Health's Annual Meeting on August 19, 2025 were approved. Details of the proposals can be found in the company's definitive proxy statement.

What were the clinical results for Jaguar Health's crofelemer in MVID and SBS-IF patients?

Initial proof-of-concept results showed crofelemer reduced total parenteral nutrition by up to 27% in the first MVID patient and up to 12.5% in the first SBS-IF patient.

What is Jaguar Health's (JAGX) strategy for developing orphan indication products?

Jaguar Health is seeking business development partnerships to license the development and commercialization of its orphan indication products, aiming to secure non-dilutive funding.

What is the regulatory pathway for Jaguar Health's crofelemer in metastatic breast cancer?

Following an FDA meeting, Jaguar Health plans to pursue a supplemental NDA strategy for crofelemer in metastatic breast cancer patients, which meets the orphan definition in the US.

When is Jaguar Health's CEO presenting company updates?

CEO Lisa Conte is scheduled to present updates on near-term catalysts at the Emerging Growth Conference on August 20, 2025.
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