New Innovators with Jane King Interview with Jaguar Health CEO Lisa Conte Spotlights Company’s Near-Term Commercial & Development Milestones

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) has announced key near-term milestones in a new Innovators with Jane King interview with CEO Lisa Conte. The company is focusing on two main activities:

1. Planned October 2024 commercial launch of FDA-approved oral mucositis prescription product Gelclair® in the U.S.

2. Progressing rare disease development with multiple investigator-initiated proof-of-concept studies for crofelemer in microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF). Results are expected by the end of 2024 and throughout 2025.

Jaguar also plans to enroll first patients for two global phase 2 studies for MVID and SBS-IF in Q4 2024. The company is continuing analysis of its pivotal phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea, with a focus on breast and lung cancer patients.

Positive

• Planned commercial launch of FDA-approved Gelclair® for oral mucositis in October 2024
• Multiple ongoing proof-of-concept studies for crofelemer in rare diseases (MVID and SBS-IF)
• Expected enrollment of first patients in two global phase 2 studies for MVID and SBS-IF in Q4 2024
• Potential for early patient access to crofelemer in EU countries based on POC and phase 2 study data
• Clinically meaningful results identified in breast and lung cancer patients in OnTarget trial for cancer therapy-related diarrhea

Negative

• Results from proof-of-concept studies not expected until end of 2024 and throughout 2025
• Phase 3 OnTarget trial results for crofelemer in cancer therapy-related diarrhea still under analysis
• Approval pathway for crofelemer in cancer therapy-related diarrhea still uncertain, pending FDA discussions

Financial Analyst

Jaguar Health's near-term milestones present a mixed outlook for investors. The planned October 2024 launch of Gelclair® for oral mucositis could potentially boost revenue in the short term. However, the impact remains uncertain without sales projections or market size data.

The company's focus on rare diseases like MVID and SBS-IF through multiple proof-of-concept studies is a high-risk, high-reward strategy. These indications typically have small patient populations but can command premium pricing if successful. The potential for early patient access in EU countries based on POC and Phase 2 data could accelerate revenue generation if results are positive.

Investors should closely monitor the OnTarget trial results for cancer therapy-related diarrhea, particularly in breast and lung cancer patients. A potential FDA approval pathway for these indications could significantly expand crofelemer's market opportunity. Overall, while Jaguar Health shows promise, its financial stability and cash runway will be important factors to watch in the coming quarters.

Medical Research Analyst

Jaguar Health's multi-pronged approach to rare disease research is strategically sound. The focus on MVID and SBS-IF, both orphan diseases with high unmet medical needs, could potentially position crofelemer as a first-in-class therapy for these conditions. The company's strategy of conducting multiple investigator-initiated studies across different regions (US, EU, MENA) is cost-effective and could provide diverse data sets to support future regulatory submissions.

The planned enrollment for two global Phase 2 studies in Q4 2024 indicates progress in the clinical pipeline. However, investors should note that rare disease trials often face recruitment challenges due to small patient populations. The potential for early patient access in EU countries based on POC and Phase 2 data is a significant advantage, potentially allowing for faster market penetration and real-world data collection.

The ongoing analysis of the OnTarget trial for cancer therapy-related diarrhea, particularly in breast and lung cancer patients, could open up a larger market opportunity if successful. This indication would address a more common side effect of cancer treatments, potentially broadening crofelemer's application beyond rare diseases.

Click here to view interview video

Paramount near-term activities include planned October 2024 commercial launch of FDA-approved oral mucositis prescription product Gelclair^® and results from independent, investigator-initiated trials of crofelemer for rare diseases

SAN FRANCISCO, CA / ACCESSWIRE / September 4, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that a new Innovators with Jane King video interview of Lisa Conte, Jaguar's founder, president, and CEO, is available and can be viewed by clicking here.

"Our paramount near-term activities are our planned October 2024 commercial launch of the FDA-approved oral mucositis prescription product Gelclair in the U.S. and progressing our rare disease development business," said Conte.

Jaguar, with strong leadership and participation from Jaguar family companies Napo Pharmaceuticals and Napo Therapeutics, is supporting multiple investigator-initiated proof-of-concept (POC) studies of crofelemer for the rare disease indications of microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) in the US, EU, and Middle East/North Africa (MENA) regions, with results expected by the end of 2024 and throughout 2025. Additionally, the company expects to enroll first patients for two global phase 2 studies for these same indications - MVID and SBS-IF - in Q4 2024. Enrollment in the POC study of crofelemer in Abu Dhabi in pediatric patients with MVID or SBS-IF is expected to begin shortly, with results expected in Q4 2024.

Conte continued, "In accordance with the guidelines of specific EU countries, published data from POC investigations and phase 2 studies in such rare diseases could support early patient access to crofelemer for these debilitating conditions in those countries. Additionally, we are continuing our analysis of our pivotal phase 3 OnTarget trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD). As announced, we are collaborating with our clinical and scientific advisers to evaluate the significance of the clinically meaningful results identified in patients with breast and lung cancer in the initial data from OnTarget, as we plan to engage in discussions with the FDA to explore the possible pathway of approval to make crofelemer available to breast and lung cancer patients for CTD."

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 at makecancerlessshitty.com and on X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will begin the commercial launch in October 2024 for Gelclair, Jaguar's expectation that the company may engage in discussions with the FDA after evaluating the significance of the clinical outcome signals from the OnTarget trial, Jaguar's expectation that an approval pathway may exist to make crofelemer available to breast and lung cancer patients for CTD, the company's expectation that results from investigator-initiated and IND proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure will be available by the end of 2024 and throughout 2025, the company's expectation, that in accordance with the guidelines of specific EU countries, published data from clinical investigations of crofelemer in MVID and SBS could support early patient access to crofelemer for these conditions in those countries, and the company's expectation that two Jaguar-sponsored global phase 2 clinical trials of crofelemer for intestinal failure associated with MVID or SBS will begin enrolling patients in Q4 2024. 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 accesswire.com

FAQ

When is Jaguar Health (JAGX) planning to launch Gelclair® in the U.S.?

Jaguar Health (JAGX) is planning to commercially launch Gelclair®, an FDA-approved oral mucositis prescription product, in the United States in October 2024.

What rare disease indications is Jaguar Health (JAGX) studying for crofelemer?

Jaguar Health (JAGX) is conducting proof-of-concept studies for crofelemer in microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF).

When does Jaguar Health (JAGX) expect results from its rare disease studies?

Jaguar Health (JAGX) expects results from its proof-of-concept studies for rare diseases by the end of 2024 and throughout 2025.

What is the status of Jaguar Health's (JAGX) OnTarget trial for cancer therapy-related diarrhea?

Jaguar Health (JAGX) is continuing analysis of its pivotal phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea, with a focus on clinically meaningful results identified in breast and lung cancer patients.