Jaguar Health Reports Approval of All Proposals at March 2025 Special Meeting of Stockholders

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced the approval of all proposals at its March 13, 2025 Special Meeting of Stockholders. The company highlighted several upcoming catalysts, including:

First results from proof-of-concept investigator-initiated trials of crofelemer for rare diseases short bowel syndrome with intestinal failure (SBS-IF) and microvillus inclusion disease (MVID) are expected in Q2 2025. Additional trial results will follow throughout 2025.

The company also reported statistically significant results in the Phase 3 OnTarget trial's prespecified subgroup of breast cancer patients using crofelemer for cancer therapy-related diarrhea (CTD). A meeting with the FDA to discuss these results is scheduled for Q2 2025.

If successful with MVID patients, crofelemer may qualify for the EMA's PRIME program and FDA's Breakthrough Therapies program, potentially expediting development and review processes.

Positive

• Statistically significant Phase 3 OnTarget trial results in breast cancer patients
• Potential fast-track regulatory pathways through EMA PRIME and FDA Breakthrough Therapy programs
• Multiple near-term catalysts with trial results expected throughout 2025

Negative

• Results from proof-of-concept trials still pending and uncertain
• FDA approval pathway still requires further discussion and clarification

Insights

Biotechnology Analyst

Jaguar Health's announcement carries meaningful clinical development implications for their lead asset crofelemer. The company has multiple near-term catalysts expected in Q2 2025, creating a concentrated period of potential value inflection points.

Most significantly, Jaguar expects first results from proof-of-concept investigator-initiated trials of crofelemer for two rare diseases: short bowel syndrome with intestinal failure (SBS-IF) and microvillus inclusion disease (MVID). These orphan indications represent high unmet medical needs where positive data could potentially qualify for expedited regulatory pathways, including the FDA's Breakthrough Therapy designation and the EMA's PRIME program.

Additionally, an FDA meeting is scheduled for Q2 2025 to discuss the statistically significant results already achieved in the Phase 3 OnTarget trial's prespecified subgroup of breast cancer patients with cancer therapy-related diarrhea. This represents their most advanced clinical program with clear regulatory definition.

The company's multi-indication strategy for crofelemer maximizes their development investment by targeting both ultra-rare diseases (potentially enabling early EU access with reimbursement) and larger market opportunities in oncology supportive care. The concentration of catalysts in Q2 2025 creates a defined timeline for potential progress across multiple programs simultaneously.

Regulatory Affairs Specialist

Jaguar Health's announcement highlights their strategic regulatory approach across multiple jurisdictions. The company is leveraging several regulatory pathways that could potentially accelerate crofelemer's development timeline if clinical data proves positive.

First, management has explicitly stated that published data from their clinical investigations in MVID and SBS-IF could support reimbursed early patient access in specific EU countries, even before formal approval. This represents a potential revenue pathway that bypasses the traditional lengthy approval process for these rare conditions.

Second, positive results in even a small number of MVID patients may qualify crofelemer for enhanced regulatory interaction programs - specifically the EMA's PRIME program and the FDA's Breakthrough Therapy designation. These designations would provide closer collaboration with regulators and potentially faster review timelines.

For their oncology program, the company has secured an FDA meeting to discuss the statistically significant results in breast cancer patients from their Phase 3 OnTarget trial. Management's stated goal is to identify the most efficient regulatory pathway for this specific patient population.

This multi-pronged regulatory strategy is well-aligned with crofelemer's development across both rare diseases and oncology supportive care, potentially creating multiple opportunities for expedited review based on unmet medical needs in these patient populations.

Jaguar expects first results in Q2 2025 of proof-of-concept investigator-initiated trials of crofelemer for the rare diseases short bowel syndrome with intestinal failure and microvillus inclusion disease

FDA meeting expected in Q2 2025 on the statistically significant results of the Phase 3 OnTarget trial of crofelemer in the prespecified subgroup of patients with breast cancer

SAN FRANCISCO, CA / ACCESS Newswire / March 13, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Special Meeting of Stockholders held on March 13, 2025 (the "Special Meeting").

Two 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 and supplemental information filed with the Securities and Exchange Commission on February 24, 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.

"Jaguar has multiple expected near-term catalysts. The Company is supporting three proof-of-concept (POC) investigator-initiated trials (IIT), and conducting two Phase 2 studies, of crofelemer, our novel plant-based anti-secretory prescription drug, for the rare diseases short bowel syndrome with intestinal failure (SBS-IF) and/or microvillus inclusion disease (MVID) in the US, European Union, and/or Middle East/North Africa regions. The first POC IIT results are expected to be available in the second quarter of 2025, with additional POC IIT results expected throughout 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions," Lisa Conte, Jaguar's president and CEO, said. "Additionally, the Company expects that if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow pathways for regulatory approval in the US and other regions and qualify crofelemer for participation in PRIME, a European Medicines Agency (EMA) program providing enhanced interaction and early dialogue with drug developers of novel medicines targeting unmet medical needs, and in the U.S. Food and Drug Administration's (FDA) Breakthrough Therapies program. If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of the drug."

Jaguar also remains focused on development of crofelemer for cancer therapy-related diarrhea (CTD). As announced, the analysis of the prespecified subgroup of adult patients with breast cancer from the Company's recently conducted Phase 3 prophylactic OnTarget clinical trial for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy indicate that crofelemer achieved statistically significant results in this subgroup. These results were the subject of a December 11, 2024 poster presentation at the San Antonio Breast Cancer Symposium. The Company has requested a meeting with the FDA to discuss the results of OnTarget in breast cancer patients and potential pathways to bring crofelemer to this patient population as efficiently as possible, and expects the meeting to take place in the second quarter of 2025.

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 and/or rare 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

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 the first POC IIT results may be available in Q2 2025 for crofelemer for SBS-IF and MVID, Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions, Jaguar's expectation that, if even just a very small number of MVID patients show benefit with crofelemer, this may potentially allow approval in the United States for crofelemer for MVID and qualify crofelemer for participation in PRIME for this indication and in the FDA's Breakthrough Therapies program, and Jaguar's expectation that a meeting with the FDA will take place in Q2 2025. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

FAQ

When will Jaguar Health (JAGX) release the first results for crofelemer in rare diseases?

Jaguar Health expects to release the first proof-of-concept trial results for crofelemer in SBS-IF and MVID in Q2 2025, with additional results throughout 2025.

What were the results of JAGX's Phase 3 OnTarget trial for breast cancer patients?

The Phase 3 OnTarget trial achieved statistically significant results in the prespecified subgroup of breast cancer patients for cancer therapy-related diarrhea.

When is JAGX meeting with the FDA to discuss the OnTarget trial results?

Jaguar Health expects to meet with the FDA in Q2 2025 to discuss the OnTarget trial results for breast cancer patients.

What regulatory benefits could JAGX receive if crofelemer shows benefits in MVID patients?

Success in MVID patients could qualify crofelemer for the EMA's PRIME program and FDA's Breakthrough Therapies program, expediting development and review.