Full Press Release Details
Enters Exclusive Crofelemer License and Commercialization Agreement with SynWorld Technologies for Canalevia for Treatment of Diarrhea
of $5.0 million, and up to $5.0 million in unregistered equity infusion, over next 24 months
of up to $5.0 million payable in unregistered Jaguar stock to SynWorld to support approval of crofelemer in China, providing Jaguar Health
with up to 80% of profits
SAN FRANCISCO, CA / June 29,
2022 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the company has entered an exclusive license and services
agreement with Ontario, Canada-based SynWorld Technologies Corporation (SynWorld) for the treatment of diarrhea in dogs in the China
market with Jaguar's Canalevia (crofelemer delayed-release tablets) prescription drug product.
"We are very excited about the
possibility of making Canalevia available in China as part of the license we have provided to SynWorld for crofelemer for treatment of
diarrhea in dogs in this territory," said Lisa Conte, Jaguar's founder, president, and CEO. "Per the terms of the agreement,
Jaguar is engaging SynWorld as a service provider to obtain regulatory approval of the product for Jaguar in China and granting SynWorld
a license to commercialize and sell this product following such approval in China. As consideration for the license, Jaguar is entitled
to receive 60% of any profits from sales of the product in China. If Jaguar reimburses SynWorld for the direct expense of obtaining regulatory
approval in China, the profit sharing will be 80% and 20%, respectively, for Jaguar and SynWorld."
The agreement also entails monthly license
fee payments by SynWorld to Jaguar amounting to US $5.0 million in total during the initial two-year term of the agreement, and a commitment
by SynWorld to make quarterly purchases of Jaguar common stock (purchased at market price in unregistered stock at the time of purchase),
amounting to US $5.0 million of Jaguar stock purchased in total, during the initial two-year term of the agreement. As consideration
for the regulatory services to be provided by SynWorld, Jaguar will pay SynWorld a monthly service fee up to U.S. $5.0 million in total
over the initial two-year term of the agreement in the form of unregistered Jaguar stock, with the value of such stock equal to market
price at the time of such issuance. Under no circumstances will stock under the agreement be issued below market price on the commencement
date of the license agreement. Additionally, under no circumstances will the number of shares of common stock issued under the agreement
(i) exceed 19.99% of the total Jaguar shares outstanding as of the date of the agreement or (ii) result in the total number
of shares of common stock held by SynWorld and its affiliates exceeding 19.99% of total Jaguar shares outstanding at any given time,
in each case unless stockholder approval is obtained. The agreement includes customary termination provisions including the right of
either party to terminate the agreement for material breach of the agreement by the other party.
"We are especially pleased with
the infusion of capital into Jaguar expected over time from this agreement. This anticipated contribution to Jaguar's financial
health not only supports these efforts to expand Canalevia availability to China, it will support Jaguar's goal of realizing value
from progress in the development of the human pipeline of crofelemer, specifically: (i) the targeted completion of enrollment by
the end of Q2, 2023 for the OnTarget Phase 3 study of crofelemer for the prophylaxis of cancer therapy-related diarrhea; and (ii) the
completion and publication of proof-of-concept data for the orphan indications of short bowel syndrome (SBS) and potentially congenital
diarrheal disorders (CDD) in 2022, supporting potential approval from the European Medicines Agency for early patient access to product
in the European Union for SBS and CDD - an effort led by Napo Therapeutics, the rare disease-focused company Jaguar established
in Europe in 2021 that has an exclusive license to crofelemer in Europe," said Conte.
Crofelemer, under the name Canalevia -CA1,
received conditional approval from the U.S. Food and Drug Administration on December 21, 2021 for the treatment of
chemotherapy-induced diarrhea (CID) in dogs in the United States, and Jaguar is currently pursuing FDA conditional approval of Canalevia
for treatment of exercise-induced diarrhea (EID) in dogs in the US. This license agreement has the potential to significantly improve
and/or expand the value of Jaguar's Canalevia-related intellectual property portfolio.
According to Frost & Sullivan's
2018 China Pet Industry Report, there were approximately 74 million pet dogs in China at the end of 2018, the number of pet-owner
households in China increased from 69.3 million in 2013 to 99.8 million in 2018, and the market size of China's overall pet industry
is projected to reach an estimated RMB472.3 billion (US $70.5 billion) by 2023 - an 800 percent increase compared to 2013.
"The Chinese pet market has been
expanding very rapidly, thanks to fast-rising pet ownership driven by a younger generation of consumers who view dogs and cats as embedded
members of the family," said Tao Wang, SynWorld's General Manager, "and this growth is projected to continue. We look
forward to creating a sales channel for the Chinese pet market and plan to directly sell Canalevia through already-existing sales and
distribution partnerships in China following approval of the product in this territory."
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'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 local and
Indigenous communities.
About Canalevia -CA1
Canalevia-CA1 (crofelemer delayed-release
tablets) is the first and only plant-based 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 currently 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
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
About SynWorld Technologies Corporation
SynWorld Technologies Corporation employs
cutting edge technology to facilitate opportunities for companies in the U.S. to reach international markets, specifically, China. This
is particularly important for publicly traded U.S. based companies who need distribution and Chinese compliance-related logistic partnerships.
About Jaguar Health, Jaguar
Animal Health, Napo Pharmaceuticals, & Napo Therapeutics
Jaguar Health 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 Animal Health is a tradename of Jaguar Health. Jaguar
Health's wholly owned subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing proprietary plant-based
human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. 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.
For more information about Jaguar, 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 regulatory approval
will be obtained for Canalevia (crofelemer delayed-release tablets) for treatment of diarrhea in dogs in China, the expectation that
an infusion of capital into Jaguar will occur over time as a result of this agreement and that this anticipated contribution to Jaguar's
financial health will support Jaguar's goal of realizing value from progress in the development of the human pipeline of crofelemer,
the expectation that enrollment will complete by the end of Q2 2023 for the OnTarget study, the expectation that proof-of-concept data
for SBS and potentially CDD will be completed and published in 2022, supporting potential approval from the European Medicines Agency
for early patient access to product in the European Union for SBS and CDD, the expectation that the agreement has the potential to significantly
improve and/or expand the value of Jaguar's Canalevia-related intellectual property portfolio, the expectation that the market