Crofelemer

The statistically significant responder analysis results for Mytesi® (crofelemer) in the Phase 3 OnTarget study's prespecified subgroup of patients with breast cancer were the subject of a December 2024 poster presentation at the San Antonio Breast Cancer Symposium Late-breaker abstract accepted by MASCC shows additional significant results for breast cancer subgroup Jaguar planning to meet with FDA in Q2 2025 to discuss possible pathways for crofelemer approval for prophylaxis of diarrhea in patients with breast cancer A second late-breaker abstract, related to the results of a screening survey of cancer patients about oral mucositis and a follow-up focus group, has also been accepted for presentation at MASCC's 2025 Annual Meeting SAN FRANCISCO, CA / ACCESS Newswire / April 15, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") family company Napo Pharmaceuticals ("Napo") today announced that the late-breaker abstract Napo submitted to MASCC on additional significant results in adult breast cancer patients from the OnTarget study has been accepted for presentation as an oral rapid e-poster at MASCC's June 26-28, 2025 Annual Meeting in Seattle, Washington . The authors include Pravin Chaturvedi , PhD, who is Jaguar's Chief Scientific Officer and Chair of Napo's Scientific Advisory Board , as well as leading oncologists and cancer patient advocates. The abstract is titled OnTarget : Crofelemer or Placebo for the Prophylaxis of Diarrhea in Adults with Solid Tumors Initiating Targeted Therapy ± Chemotherapy (Tt/C) "We're very pleased about the acceptance by MASCC of this new abstract, which describes the proportion of breast cancer patients who were continuous responders for the entire 3-month period of the OnTarget trial compared to breast cancer patients in the placebo arm of the study," said Lisa Conte , Jaguar's president and CEO. "As a cancer patient, having options to manage the side effects of life saving drugs is very important. I believe the published results of crofelemer for the prophylaxis of cancer therapy-related are very exciting and compelling," said Dr. Kelly Shanahan , a former clinician and a metastatic breast cancer patient who serves on Napo's Scientific Advisory Board (SAB). As announced, the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in Napo's Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy. The American Cancer Society expects 316,950 new cases of breast cancer diagnosed in women in the US in 2025,1 and it's estimated that there were 4 million US women with a history of invasive breast cancer in 2022.2 "Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, or cessation of treatment altogether, all of which can impact patient outcomes. We are very happy to have been granted a meeting with the FDA to review the positive OnTarget results in breast cancer patients and our goal is to discuss the most efficient pathways to make crofelemer - our novel, oral plant-based prescription medicine - available to this patient population for cancer therapy-related diarrhea (CTD)," said Conte. Members of Napo's SAB are expected to join Jaguar representatives at the FDA meeting in the second quarter of 2025. As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary endpoint for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup. Napo today also announced that a second late-breaker abstract, related to the results of a recent Napo-sponsored screening survey of cancer patients about oral mucositis and a follow-up focus group, has also been accepted for presentation at MASCC's 2025 Annual Meeting. The abstract is titled Beyond the Pain: Patient Insights on Oral Mucositis in Cancer Treatment. "Oral mucositis is a common, painful, and life-altering side effect of cancer treatment, frequently disrupting eating, speaking, sleeping, and social interactions. Capturing real-world patient experiences and insights can help to identify patient priorities and co-create solutions to support prevention and management of oral mucositis and enhance quality of life," said Stacey Tinianov , 11-year cancer survivor and founder of Advocates for Collaborative Education who serves on Napo's SAB . "I am delighted and honored that the results of the screening survey and focus group will be presented at MASCC's Annual Meeting this June." Ms. Tinianov coordinated the screening survey and focus group in conjunction with cancer patients who serve as Ambassadors for Napo's ongoing Make Cancer Less Shitty (MCLS) patient advocacy program. 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. "Oral mucositis has impacted my daily life constantly since 2016. Without proper supportive care, I have raw mouth sores and ulcerations from my gums and lips all the way down my throat. When severe, it impacts what I am able to eat, how I'm able to eat, and sometimes my ability to talk. The pain and irritation from oral mucositis affects my sleep and my self-confidence," said JJ Singleton, a metastatic colon cancer survivor and an Ambassador for Napo's MCLS patient advocacy program. MASCC is an international, interdisciplinary organization dedicated to the practice, education and research of supportive care in cancer. The organization's mission is to continually improve the supportive care of people with cancer - from diagnosis through to survival or end-of-life 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 on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Napo will meet with the FDA in the second quarter of 2025 to discuss the results of the OnTarget study in breast cancer patients and potential pathways to bring crofelemer to this patient population as efficiently as possible for treatment of CTD, and the expectation that two Napo abstracts will be presented at MASCC's 2025 Annual Meeting. 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 Facts & Figures 2025, American Cancer Society 2 Miller KD, Siegel RL, Lin CC, et al. Cancer treatment and survivorship statistics, 2022. CA Cancer J Clin. 2022:1-23 Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.

Gelclair® is the company's third commercialized prescription product Oral mucositis, also called "chemo mouth," a painful inflammation of the mouth's mucous membranes, has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force Napo's core target patient audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients SAN FRANCISCO, CA / ACCESS Newswire / April 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals ("Napo") is exhibiting at the 50th anniversary Oncology Nursing Society (ONS) Congress taking place April 9-13, 2025 in Denver, Colorado as part of ongoing commercial activities for Gelclair. "We have expanded our footprint beyond HIV-related supportive care to include cancer-related supportive care, and our recent in-licensing of the FDA-approved oral mucositis product Gelclair is a first building block," said Lisa Conte , Jaguar's president and CEO. "Cancer is chaotic, because patients feel a loss of control - over their life, their treatment, and their supportive care needs," said Conte. "Jaguar's mission is to change patients' lives for the better, especially in the area of supportive care for complex disease states like cancer. We look forward to driving awareness among the oncology nursing community at ONS about Gelclair. Oral mucositis, also called "chemo mouth," is among the most common, painful, and debilitating cancer treatment-related side effects, and it is undertreated and underappreciated. We believe we can help cancer patients by giving them a supportive care product for oral mucositis that provides soothing, quick, and lasting pain relief without stinging, drying or burning." "If it weren't for Gelclair, I don't know if I would have continued with chemo. It was that painful. Gelclair gave me relief when nothing else did - it allowed me to keep going," said Megan-Claire, a Gelclair patient brand ambassador for Napo. 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 chronic 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 of 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." Napo's core target audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients, and oncology-focused health care professionals. Head and neck cancers account for nearly 4 percent of all cancers in the United States , according to the National Cancer Institute (NCI).1 Counting cancers of the oral cavity, pharynx, and larynx, the NCI estimates that about 71,110 cases were diagnosed in the U.S. in 2024.2 Approximately another 23,000 patients each year undergo bone marrow transplant procedures. Oral mucositis has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force.3 Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy.4 Of the latter, 19% may end up being hospitalized, experiencing a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis, and an increase in patient management costs.4 Oral mucositis impacts a patient's ability to swallow, speak, eat, and drink - and may lead to cancer treatment discontinuation.5 It is estimated that at least 11% of head and neck cancer patients experience cancer treatment interruption due to oral mucositis.6 "Those of us working in the oncology field know the impact that side effect-related delays or cessation of cancer treatment can have on overall survival and on the efficacy of treatment," Conte said. "Of patients with head and neck cancers treated with chemotherapy and radiotherapy who develop oral mucositis, half of the cases are typically considered severe - meaning oral mucositis of grade 3 or 4, which may require hospitalization and may require parenteral nutrition and IV hydration, and the morbidity and expense associated with those interventions." Jaguar also remains focused on development of crofelemer for cancer therapy-related diarrhea (CTD). As announced, the analysis of the prespecified subgroup of adult patients with breast cancer from Napo's recently conducted Phase 3 prophylactic OnTarget clinical trial for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy indicates that crofelemer achieved statistically significant results in this subgroup. These results were the subject of a December 11, 2024 poster presentation at the San Antonio Breast Cancer Symposium and the late-breaker abstract recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC) for consideration for presentation at the June 2025 MASCC Annual Meeting. As also announced, the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in OnTarget . The company's goal is to discuss the most efficient pathways to make crofelemer available to this patient population for CTD. 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. 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. Please see full Prescribing Information at: https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.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 (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 on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Napo will exhibit at the April 2025 ONS Congress , and the expectation that Napo will meet with the FDA in the second quarter of 2025 regarding the statistically significant results of the OnTarget trial in the prespecified subgroup of patients with breast cancer. 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 https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet 2 https://www-aacr-org.libproxy1.nus.edu.sg/patients-caregivers/awareness-months/head-and-neck-cancer-awareness-month/ 3 NCCN Task Force Report : Prevention and Management of Mucositis in Cancer Care . Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw , 6(S1), S-1-S-21. https://doi-org.libproxy1.nus.edu.sg/10.6004/jnccn.2008.2001 4 Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7 ;39(1):210. doi: 10.1186/s13046-020-01715-7. PMID: 33028357; PMCID: PMC7542970 5 Vera-Llonch M , Oster G, Hagiwara M, Sonis S. Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer. 2006;106(2):329-336. doi:10.1002/cncr.21622. 6 Trotti A, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8 . PMID: 12742264. Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.