Jaguar planning to begin commercial launch of FDA-approved Gelclair prescription gel for oral mucositis (also called "chemo mouth") in Q3 2024

Company to feature "Make Cancer Less Shitty" patient advocacy program at ONS Congress

SAN FRANCISCO, CA / ACCESSWIRE / April 22, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals ("Napo") is exhibiting at the Oncology Nursing Society (ONS) Congress taking place April 24-28, 2024 in Washington, DC.

"We look forward to driving awareness among the oncology nursing community at this event about Jaguar's expanding focus on cancer supportive care," said Lisa Conte, Jaguar's president and CEO. "We are expanding our footprint beyond HIV-related supportive care to include cancer-related supportive care, and our recent in-licensing of the oral mucositis product Gelclair is a first building block. Results are forthcoming for our pivotal Phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea, an indication we also refer to as chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as unpredictable and/or chronic debilitating diarrhea and GI urgency."

Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Also called "chemo mouth," oral mucositis has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network (NCCN) task force.¹ An FDA-approved prescription product, Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth.

"Nurses play a vital role in providing integrated supportive care to cancer survivors to meet various physical, psychological, and social support needs," added Conte. "Jaguar and Napo acknowledge the rigors of both short-term and perpetual treatment and do not believe any cancer therapy-related side effect, whether it is extreme fatigue, debilitating diarrhea, oral mucositis, hair loss, chronic pain, or others, should ever be viewed as 'acceptable' or 'tolerable.' We live in the age targeted therapies, and thanks to these amazing drugs cancer patients are living longer - 5, 10, 20 years. Targeted therapies often lead to more severe side effects, however, and patients want to live, not just survive."

"I am pleased to announce that, in keeping with our deep commitment to the dignity and quality of life of cancer patients, the "Make Cancer Less Shitty" initiative will also be a key feature of Napo's presence at the ONS Congress," Conte said. "The MCLS program launched in December 2023 at the San Antonio Breast Cancer Symposium, and the program has been expanded to include a makecancerlessshitty.com website and pages on X, Facebook and Instagram. The program goal 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."

The annual ONS Congress is a prominent event for professionals and organizations who are committed to the promotion of excellence in oncology nursing and the transformation of cancer care. ONS is a professional association that represents 100,000 nurses and is the professional home to more than 35,000 members. ONS is committed to promoting excellence in oncology nursing and the transformation of cancer care. Since 1975, ONS has provided a professional community for oncology nurses, developed evidence-based education programs and treatment information, and advocated for patient care, all in an effort to improve the quality of life and outcomes for patients with cancer and their families. Learn more at www.ons.org.

About Gelclair

INDICATIONS

GELCLAIR has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

IMPORTANT SAFETY INFORMATION

Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.

No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.

If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.

If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.

Visit www.fda.gov/safety/medwatch, call 1-855-273-0468 or fill-in the form at this link.

Please see full Prescribing Information at:

https://gelclair.com/assets/Gelclair_PI_Decemeber_2021.pdf

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 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

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Visit Jaguar on LinkedIn: https://www.linkedin.com/company/jaguar-health/

Visit Jaguar on X: https://twitter.com/Jaguar_Health

Visit Jaguar on Instagram: https://www.instagram.com/jaguarhealthcommunity/

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that results are forthcoming for Jaguar's OnTarget trial. 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. 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 Oronsky B, et al. Transl Oncol. 2018;11(3):771-778.

Source: Jaguar Health, Inc.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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