News Release Details

Canalevia^®-CA1, which received conditional approval from the FDA on December 21, 2021, is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA

SAN FRANCISCO, CA / ACCESSWIRE / October 27, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that the company sponsored the October 26, 2022 episode of dvm360 Live!^™, a web-based, magazine-style talk show for veterinary professionals hosted by Adam Christman, DVM, MBA, to drive awareness of the company's Canalevia-CA1 drug product and encourage veterinary clinics to contribute canine cancer records to the Take C.H.A.R.G.E. (Canine Health And ReGistry Exchange) initiative.

Dr. Sue Ettinger, DVM, DACVIM (Oncology), also known as Dr Sue Cancer Vet^®, appeared on the October 26, 2022 episode of dvm360 Live! to discuss Canalevia-CA1. She was joined on the show by one of her canine patients, a Labrador mix undergoing chemotherapy for sarcoma, and the dog's owner, who discussed his pet's experience with Canalevia-CA1. Dr. Ettinger is also a member of the Take C.H.A.R.G.E. Scientific Advisory Board.

Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Due to the increasing number of chemotherapeutic agents being adopted by veterinarians and veterinary oncologists, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,¹ and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the U.S. veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Launched in May 2022, the Take C.H.A.R.G.E. registry is the first U.S.-based national cancer registry tracking the incidence and prevalence of cancer in dogs. Information on the impact of canine cancer by breed, type, age, gender, and location is provided on an open access, easy to use, interactive dashboard. Starting with nearly 36,000 anonymous canine patient records and 830 confirmed cancer diagnoses, the Take C.H.A.R.GE. registry provides foundational incidence and prevalence data to the veterinary community and dog owners to help guide diagnosis and treatment decisions at no cost to clinics or dog owners.

"We established Take C.H.A.R.G.E. to fill a major research gap among the veterinary community and dog owners in the United States because, until now, there has been no nationally-based dog owner survey or registry focused on canine cancer," said Jaguar Health founder, president and CEO Lisa Conte. "The information from Take C.H.A.R.G.E. will provide the first ever national representation of the incidence and prevalence of canine cancer and will help inform decisions that advance the quality of life of both dogs with cancer and their owners. As we continue to enhance the registry, we plan to incorporate a comprehensive coding system to enable accurate comparison of canine cancers in the United States to help make it easier to understand and treat canine cancer. Data from Take C.H.A.R.G.E. may also provide insights to help better understand cancer in humans."

dvm360 Live! features in-depth clinical discussions with leaders in veterinary medicine, trending veterinary news, and inspiring veterinary stories and interviews. Dr. Christman, Chief Veterinary Officer of dvm360^®, is also a national animal health advocate, speaker, and social media influencer with thousands of TikTok and Instagram followers. dvm360 Live! can be viewed at dvm360.com and on all dvm360 social media channels.

dvm360^® has been a leading multi-media provider of animal health care communications, education, and research for veterinary professionals for over 50 years.

About Crofelemer

Crofelemer is a novel, oral plant-based medicine extracted and purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Jaguar Health's wholly owned subsidiary, 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 Canalevia^®-CA1

Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is an oral formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for a full approval. Jaguar has received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 70,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.

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.

About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that information from Take C.H.A.R.G.E. will provide the first ever national representation of the incidence and prevalence of canine cancer and will help inform decisions that advance the quality of life of both dogs with cancer and their owners, and Jaguar's expectation that data from Take C.H.A.R.G.E. may also provide insights to help better understand cancer in humans. 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 a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. 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 Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.