News Release Details

Company's Canalevia^®-CA1 (crofelemer delayed-release tablets) prescription drug is FDA conditionally approved for treatment of chemotherapy-induced diarrhea (CID) in dogs and is the first and only treatment for CID in dogs to receive any type of approval from FDA

SAN FRANCISCO, CA / ACCESS Newswire / May 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") is proud to be celebrating National Pet Cancer Awareness Month, a time devoted to raising awareness about cancer in pets, particularly in dogs and cats.

"According to the American Veterinary Medical Association, approximately 1 in 4 dogs will, at some stage in their life, develop cancer, and almost 50% of dogs over age 10 will develop cancer,"¹ said Lisa Conte, Jaguar's founder, president, and CEO. "Dogs get cancer at roughly the same rate as people. While there is less information about the rate of cancer in cats, some cancers, such as lymphoma, are more common in cats than in dogs."¹

According to the National Cancer Institute, which is part of the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.

Canalevia^®-CA1, Jaguar's U.S. Food and Drug Administration (FDA) conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available on Chewy and from veterinarians across the U.S. By prescription only, Canalevia-CA1 is a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based product sustainably harvested from the Croton lechleri tree.

"Our deep commitment to supportive cancer care is a core message of our ongoing "Make Cancer Less Shitty" patient advocacy program, which seeks to broadly acknowledge the rigors of both short-term and perpetual cancer treatments for metastatic patients," Conte said. "The goal of the MCLS program is to drive awareness of cancer supportive care gaps and needs, bring together patients, advocates, researchers, and clinicians, and, most importantly, to amplify the voice of patients about the importance of supportive 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, 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

Important Safety Information About Canalevia-CA1

For 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.

Forward-Looking Statements

Certain 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.

¹ "Cancer in Pets." American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

Contact:

hello@jaguar.health

Jaguar-JAGX

SOURCE: Jaguar Health, Inc.