Jaguar Health Inc (JAGX)

[TJG]

Again READ THE DEF 14, its a process to get thru it... but it is clearly telling you that they will not put out the results until after the vote has been done...

There is a section and NO I WILL NOT DO THE WORK FOR YOU, that if you read it it states that the deal that was struck with lender on Feb 27 where they struck the deal to convert the Series J shares for commons will not get done with out this reverse split being approved...

Now if you stop and think, which some here can not do, with out that deal getting done the releasing the Phase III results will not get this to the level that is needed because those Series J shares can be converted as of a month or so back. There will not be a lock down on the 180,000,000 shares that are becoming common shares based on the swap over from Series J to commons... with out that lock down Fife will simply dilute those shares into any run up that a positive phase III result would produce. Do what you want vote how you want but dont think that the results are coming out before the vote.

One last thing this is from the PR announcing that the results would come in the first quarter... notice it say, They expect that they will be available by the end of Q 1. The word Anticipate is the out for Lisa... she will simply say... We expected they would be done, but as of now they wont be completed until sometime in the second quarter. You can read it here on their web page this is the link to it and the transcript Scroll down the text and you will see I have highlighted the announcement of Q 1 2024 release of the data

https://jaguarhealth.gcs-web.com/news-releases/news-release-details/majority-subjects-jaguar-healths-placebo-controlled-pivotal


December 11, 2023
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Stage II completed; comprehensive results expected in Q1 2024; company's planned regulatory pathway for FDA approval remains on track

Cancer patients at patient advocacy events voice strong support for company's focus on patient quality of life and the highly neglected need for new therapies for cancer therapy-related diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / December 11, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company, today announced that a majority of subjects in the company's placebo-controlled pivotal Phase 3 OnTarget trial for prophylaxis (prevention) of diarrhea in adult cancer patients receiving targeted therapy with or without standard chemotherapy chose to continue on to Stage II of the two-stage trial.

After completing the Stage I double-blind, placebo-controlled primary prophylactic treatment phase of OnTarget, subjects had the option to remain on their blinded assigned treatment arm and reconsent to enter into the Stage II extension phase.

"We are very pleased that a majority of subjects chose to continue on to Stage II while recognizing that their requirement to remain blinded would continue," said Lisa Conte, Jaguar's president and CEO. "We are deeply committed to all patients who participated in the OnTarget trial. We view them as key stakeholders and we thank them for their support and participation in this study."

Stage II of the trial has concluded. Inclusion of Stage I data and Stage II data, with success, is required in the supplemental NDA filing of crofelemer to add the indication for prophylaxis of diarrhea in cancer patients receiving targeted therapy with or without standard chemotherapy.

"Since all patient data will be included in the final locked database, we will remain blinded and will announce the comprehensive results of the full trial, including Stage II results, rather than proceeding with the original plan of announcing top line results for Stage I only. We expect the full trial results to be available in the first quarter of 2024," Conte said. "The clinical trial database includes patients with multiple solid tumor types, and the trial allowed the inclusion of 24 different targeted therapies, including multiple important mechanisms of action for targeted therapy drugs."

OnTarget is a first-of-its-kind, 24-week (two 12-week stages) clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea, an indication Napo also refers to as preventive treatment of chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as chronic and/or episodic debilitating diarrhea (loose and/or watery stools), urgency, bowel incontinence and abdominal pain and discomfort.

Diarrhea is a common side effect of targeted therapies and new treatments are needed. Up to 95% of patients on tyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used.1 The OnTarget study is testing whether the company's plant-based prescription drug crofelemer (versus placebo) can prevent (or substantially reduce) diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies (that are associated with diarrhea in at least 50% of patients) is initiated.

"We are excited as any stakeholder to see the results. We own the expectation we set that data would be available in November 2023. We have to respect and abide by the requirements and Standard Operating Procedures of our third-party service providers and work with them as we meet GCP (Good Clinical Practice) requirements, particularly when conducting a complex global Phase 3 clinical trial," Conte said. "These service providers have important quality control procedures that take time and somewhat expand as the data analysis process progresses. We are working with all vendors that are critical to ensure the integrity of the data. Jaguar and Napo personnel continue to remain blinded to the study results at this time."

Napo's abstract outlining the design of the OnTarget trial, the importance of patient reported outcomes, and the neglected medical need of CIOB was the subject of a poster presentation on December 7, 2023 at the San Antonio Breast Cancer Symposium (SABCS). More than two dozen leading patient advocacy groups provided powerful voices at events hosted by Napo, highlighting the neglected need of mitigating diarrhea in patients receiving cancer therapies, and expressing strong support for the company's focus on patient quality of life.

About Crofelemer

Crofelemer is the only oral prescription drug approved under FDA botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Jaguar family company 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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted 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