Latest news with #JaguarHealth
Associated Press
4 days ago
- Business
- Associated Press
First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
Two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of crofelemer from CID to treatment of general, non-infectious diarrhea in dogs Jaguar in discussions with potential partners to license and fund development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs SAN FRANCISCO, CA / ACCESS Newswire / June 11, 2025 / Jaguar Health, Inc. ( NASDAQ:JAGX ) (Jaguar), under its Jaguar Animal Health tradename for the veterinary market, today announced that the first study site has been established for Jaguar's field study of 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. Jaguar has two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) in dogs and to expand the indication of crofelemer from CID in dogs to treatment of general, non-infectious diarrhea in dogs. The company is in discussions with potential partners to fund development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally. 'We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs, and believe there is clearly an unmet medical need for a product for the much larger market of treatment of general, non-infectious diarrhea in dogs,' said Lisa Conte, Jaguar's Founder and CEO. 'We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to identifying a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in the U.S and/or globally. Forging a partnership for this purpose is a key focus of our business development efforts in 2025 and has been designated as a key potential catalyst for the company this year.' 'Jaguar's canine-focused business development efforts align with our ongoing business development efforts on the 'human' side of the company for crofelemer - the catalysts for which are the pathways discussed with the FDA to bring crofelemer to metastatic breast cancer patients, a population we feel meets the requirements for orphan drug status; and the prompt establishment of an expanded access program for crofelemer for the ongoing important unmet medical need of cancer therapy-related diarrhea in breast cancer patients; and the initial proof-of-concept results from the ongoing investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer in Abu Dhabi in pediatric patients with intestinal failure due to the orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). As recently announced, the initial proof-of-concept results of this IIT show crofelemer reduced the required total parenteral nutrition (TPN) and/or supplementary intravenous fluids, collectively referred to as parenteral support, in patients with intestinal failure due to MVID and short bowel syndrome by up to 27% and 12.5% respectively.' The objective of the prospective, randomized, open-label field study in dogs undergoing chemotherapy treatment across the U.S. is to collect real-world data to demonstrate real-world evidence of the clinical effectiveness for Canalevia-CA1 for the treatment of CID in dogs to support potential full FDA approval of the drug for this indication. Dogs enrolled in this study will be randomly assigned to receive a prescription of Canalevia-CA1 as a treatment for CID or be randomly selected to the control group. As announced, Jaguar established a new Investigational New Animal Drug (INAD) file with the FDA's Center for Veterinary Medicine for crofelemer to treat general, non-infectious diarrhea in dogs. Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved drug to treat canine general, non-infectious diarrhea. According to the American Veterinary Medical Association, there were an estimated 89.7 million dogs in the United States in 2024, with nearly half (45.5%) of U.S. households owning a dog in 2024. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don't have easy access to outdoor facilities is a significant problem for families with dogs. Canalevia-CA1, a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, is available from multiple leading veterinary distributors in the U.S., including Chewy. About Conditional Approval and Full Approval Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA's conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the 'substantial evidence' standard of effectiveness for full approval. The conditional approval is valid for one year. The drug company can ask the FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving 'substantial evidence of effectiveness' for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug. About Chemotherapy-induced Diarrhea (CID) in Dogs 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 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. Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, 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,2 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. Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs. About Canalevia®-CA1 Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific 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 full approval. Jaguar has also 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 80,000 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. About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, 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. 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 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. 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 Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit 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 it will identify a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S and/or globally, Jaguar's expectation that the U.S. population of metastatic breast cancer patients meets the requirements for orphan drug status, Jaguar's expectation that it will promptly establish an expanded access program for crofelemer for cancer therapy-related diarrhea in breast cancer patients, and Jaguar's expectation that the field study of Canalevia-CA1 for the treatment of CID in dogs will support potential full FDA approval of the drug for this indication. 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 'Cancer in Pets.' American Veterinary Medical Association, 2021, 2 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: [email protected] Jaguar-JAGX SOURCE: Jaguar Health, Inc. press release
Miami Herald
6 days ago
- Business
- Miami Herald
REMINDER: Jaguar Health to Conduct Fireside Chat 9AM ET June 10 as Part of Lytham Partners' Spring 2025 Spotlight Series
Click here to register Discussion will focus on company's May 2025 meeting with the FDA to review the statistically significant responder analysis results for the subgroup of breast cancer patients in company's recently conducted Phase 3 OnTarget trial The currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, in alignment with company's core focus on orphan diseases Company plans to promptly pursue authorization to initiate expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today issued a reminder that Lisa Conte, the company's founder, president and CEO, will participate in a virtual fireside chat at 9:00 AM Eastern tomorrow, Tuesday, June 10, 2025, as part of Lytham Partners' spring 2025 Spotlight Series. Participation Instructions for Jaguar Health's Virtual Fireside Chat During Lytham Partners Spring 2025 Spotlight Series When: Tuesday, June 10, 2025 from 9:00 - 10:00 AM Eastern Where: Online (Click Here). The fireside chat will also be available for replay following the event. 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 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 Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit 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 Jaguar management will participate in a virtual fireside chat June 10, 2025 as part of Lytham Partners' spring 2025 Spotlight Series, Jaguar's expectation that the currently estimated US metastatic breast cancer population may qualify as an orphan population, and Jaguar's expectation that it will promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer patients. 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. Source: Jaguar Health, Inc. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.
Miami Herald
7 days ago
- Business
- Miami Herald
Jaguar Health to Conduct Fireside Chat June 10 Regarding Company's Efforts to Further its Orphan Disease Development Programs as Part of Lytham Partners' Spring 2025 Spotlight Series
Click here to register SAN FRANCISCO, CA / ACCESS Newswire / June 6, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will participate in a virtual fireside chat at 9:00 AM Eastern on Tuesday, June 10, 2025, as part of Lytham Partners' spring 2025 Spotlight Series. The discussion will focus on Jaguar's ongoing efforts to further its orphan disease development programs. Participation Instructions for Jaguar Health's Virtual Fireside Chat During Lytham Partners Spring 2025 Spotlight Series When: Tuesday, June 10, 2025 from 9:00 - 10:00 AM Eastern Where: Online (Click Here). The fireside chat will also be available for replay following the event. 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 Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit 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 Jaguar management will participate in a virtual fireside chat June 10, 2025 as part of Lytham Partners' spring 2025 Spotlight Series. 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. Contact: hello@ SOURCE: Jaguar Health, Inc.
Yahoo
06-06-2025
- Business
- Yahoo
Jaguar Health to Conduct Fireside Chat June 10 Regarding Company's Efforts to Further its Orphan Disease Development Programs as Part of Lytham Partners' Spring 2025 Spotlight Series
Click here to register SAN FRANCISCO, CA / / June 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will participate in a virtual fireside chat at 9:00 AM Eastern on Tuesday, June 10, 2025, as part of Lytham Partners' spring 2025 Spotlight Series. The discussion will focus on Jaguar's ongoing efforts to further its orphan disease development programs. Participation Instructions for Jaguar Health's Virtual Fireside Chat During Lytham Partners Spring 2025 Spotlight Series When: Tuesday, June 10, 2025 from 9:00 - 10:00 AM Eastern Where: Online (Click Here). The fireside chat will also be available for replay following the event. 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 Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit 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 Jaguar management will participate in a virtual fireside chat June 10, 2025 as part of Lytham Partners' spring 2025 Spotlight Series. 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. Contact: hello@ SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-05-2025
- Business
- Yahoo
Q1 2025 Jaguar Health Inc Earnings Call
Lisa Conte; President, Chief Executive Officer, Director; Jaguar Health Inc Carol Lizak; Chief Financial Officer; Jaguar Health Inc Operator Greetings, and welcome to Jaguar Health's May 15, 2025, investor webcast. Before I turn the call over to management, I'd like to remind you that management may look -- forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including product development stage, which may not achieve scientific objectives or meet stringent regulatory statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes its assumptions, expectations, and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and Risk Factors sections of the company's Form 10-K for the year 2024, which was filed March 31, 2025, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss and are not substitute for or superior to measures of financial performance in conformity with conference is being recorded. At this time, it's my pleasure to turn the call over to your host, Lisa Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours. Lisa Conte Thank you very much. Rob, and thank you for the introduction. Again, my name is Lisa Conte. And I -- as usual, I may use the words Jaguar and Nepo interchangeably to refer to our company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the first quarter of our net revenue decreased in Q1 2025 versus Q4 2024. This was mostly driven by increased sales and higher distribution chain inventory levels in the fourth quarter of 2024, which resulted in fewer purchases in Q1 of 2025. This is in contrast to dispensed prescriptions for Mytesi, crofelemer which I am pleased to announce increased in the first quarter of 2025 versus the first quarter of 2024 by approximately 2%. This is an indication of increased demand and that more patients are receiving treatment for HIV-related diarrhea from move on to the bigger picture for Jaguar. This is the year of convergence of key catalysts for Jaguar. Catalysts that we feel will be transformational in terms of the value they bring to all the stakeholders in the company. and this includes paradigm-shifting medicines and mechanisms of action to address patient supportive care, comfort, dignity, as well as disease progression modification, ability to stay on life-saving medicines and standard of care and recap our -- both our recent and upcoming catalysts, on April 30, we released initial results from an independent proof-of-concept study in pediatric patients of a novel liquid formulation of crofelemer, a highly concentrated liquid formulation, which is distinct product from Mytesi, and crofelemer, of course, is our first-in-class plant-based prescription drug and this was for intestinal failure associated with MVID, microvillus inclusion disease.I'm going to refer to this as MVID. It's an ultra-rare disease. And also results that we released on that same date April 30 for intestinal failure associated with short bowel syndrome, which I'll refer to SBS-IF, another rare what is intestinal failure? Intestinal failure is the condition where patients cannot adequately absorb the necessary nutrients of life: carbohydrates, protein, fats, vitamins, electrolytes, et cetera. The necessary absorption to sustain with intestinal failure due to MVID and often short bowel syndrome, but with MVID required total parenteral nutrition, TPN, up to 7 days a week for more than 20 hours a day, and also are suffering from devastating diarrhea like everything that goes in, goes right out, the dehydration associated with that, electrolyte imbalance and more total parenteral nutrition, to be graphic here, it's a medical feeding method where nutrients are delivered directly into a vein through an IV line bypassing the digest system. So chronic TPN has the risk of morbidity and mortality, infections from the lines, metabolic implications, LER and kidney disease problems, neurodevelopment delay, it's a catastrophic chronic it impacts in addition to all these medical issues, obviously, quality of life of both patients and their caregiver community. These patients are in a highly fragile state and children, in particular, with intestinal failure are off nor curves failing to thrive and MVID patients have a short life. They typically die at age of 11 or MVID patients, again, TPN is necessary from the first day of birth to survive. If they are not initially diagnosed and not put on TPN, they do not survive. There are no approved drug treatments for MVID or anything that we're aware of in development. The biggest impact we could have on a patient with intestinal failure, is an achievement of reduction in the quality and the time on initial proof-of-concept results that we issued on April 30 showed that crofelemer reduced TPN in the first MVID patient to participate in the study by up to 27%, and for the first pediatric SBS patients by up to 12.5%. And I should say so far, there's -- these patients will continue on an open-label basis on crofelemer for some results are groundbreaking. And they have the opportunity to modify disease progression for this catastrophic patient condition internal failure. These initial results are potentially transformative for the patients in their caregiving community, and it's not possible to overstate the significance of reduction in results were presented April 26, 2025, at the Annual Elite Ped-Gi Conference, which was hosted by Dr. Mohamad Miqdady, he also presented the results, and he is a recognized leader in pediatric gastroenterology. This is conference, his brain trial that he established over 12 years ago. I think this was the 13, 14, 15 annual, and he serves as the Chief of Pediatric Gastroenterology, Hepatology and Nutrition at the Sheikh Khalifa Medical City in Abu is the principal investigator for this ongoing exploratory single-arm, open-label, nonrandomized study for MVID and pediatric SBS patients and he's a member of our Scientific Advisory Board. This conference was a major international event, there were over 150 health care professionals after his presentation on April 26, Dr. Miqdady and his colleague, (inaudible) took part in an extemporaneous fireside chat to discuss the initial findings of this study. And in a few minutes, we're going to replay the recording for you of that fireside chat in case anyone participating today did not take part or did not get a chance to hear this fireside chat in our April 30 Investor fireside chat was moderated by my longtime colleague in Jaguar's long term colleague, Dr. Province Davidi, the Chief Scientific Officer of Jaguar and Napo and the Chair of our Scientific Advisory Board. (inaudible) is the founder of the Pediatric Gastrointestinal Department at (inaudible), Children's Specialty Hospital in an Adjunct Clinical Assistant Professor at Mohamad Bin Rashid University of Medicine and Health in Dubai. He is also an investigator and key opinion leader in another trial of -- and as I said, you're going to see the real time medical reaction to these extraordinary fireside chat was just moments after those results were rare disease programs have been in the works at Jaguar for close to 8 years. And we have been developing close working relationships with KOLs, principal investigators around the world conducting regulatory interactions, developing protocols and endpoint definition, formulation development. These first proof-of-concept results are also catalyst to enhance potential business development plans for partnering with a goal of achieving funding through access and license fees for the extraordinary based development and success Jaguar has achieved over the important results put us in a position to close collaboration -- potentially close collaborations with receipt of nondilutive dollars, as I mentioned, access fees and license fees. And there are many large deal precedents in the orphan drug space and several with much less clinical data, even preclinical opportunities at the time of deal short bowel syndrome affects approximately 10,000 to 20,000 people in Europe and roughly the same in the United States. MVID in that is an orphan designation, and we do have orphan designation for short bowel syndrome. MVID for which we also have orphan designation is an ultra-rare condition with an estimated prevalence of just a couple of hundred patients this situation, initial results in a very small number of MVID patients showing benefit with crofelemer may allow us to lower pathways for expedited regulatory approval for this indication including the FDA of Europe, European Medicine Agency's program for expedited and assisted regulatory approval, full approval in the 27 countries of the EU and FDA's Breakthrough Therapy program for expedited regulatory approval in the United States, and we've already had preliminary interactions with PRIME officials at the Jaguar in collaboration with Napo Therapeutics in Italy is currently supporting 2 ongoing proof-of-concept investigator-initiated trials in addition to the one that we've mentioned with Dr. Miqdady and also conducting 2 levo-controlled Phase II trials with crofelemer, one for MVID and one for adult short bowel syndrome intestinal failure, these trials are global in the U.S., Europe and MENA region, as you typically do with orphan-designated in addition to Dr. Miqdady, there is an investigator-initiated trial in adult patients with short bowel syndrome intestinal failure at Cleveland Clinic. And between these 2 studies, we expect to have proof of concept results from these investigator-initiated trials throughout 2025 and potentially even into 2026. At the same time, simultaneously running are the placebo-controlled Phase II trials for MVID and SBS, and they are expected to conclude and have results in the first half of 2026. So a lot, a lot, a lot of news associated with our rare disease again, a convergence of results and important news based on almost 8 years of planning and development work on the part of the moving on to our other core crofelemer development program, which also has a convergence of catalyst happening right now. OnTarget, was a global Phase III prophylactic clinical trial conducted by Jaguar, again, prophylaxis for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. It was a big (inaudible) study, a big hug around the cancer community, including all solid tumor types, 24 different targeted agents again, with or without cytotoxic are targeted agents? Those are those agents that targeted [ CDK4/6 ] epidermal growth factor receptor antibodies, tyrosine kinase inhibitors, taken chronically, by metastatic patients and often 9 to 18 months in a cure the situation to keep the cancer at bay. We did not achieve statistical significance in this big bold study. However, the analysis in adult breast cancer patient indicates that crofelemer achieved significant results, statistically significant results in this prespecified subgroup the patients with breast cancer accounted for approximately 65% or 183 of the 287 participants in this results in breast cancer patients were the subject of an accepted poster presentation in December 2024 at the acclaimed San Antonio Breast Cancer Symposium, an additional significant results in adult breast cancer patients from this OnTarget study have been accepted for presentation at the Multinational Association of Supportive Care and Conference, MASCC annual meeting next month in FDA has granted Jaguar, Jaguar-Napo again, we use those were named interchangeably -- a Type C meeting now the second quarter of 2025. To discuss the responder analysis, the statistical analysis in this prespecified subgroup of patients with breast cancer with prophylaxis with crofelemer for diarrhea, targeted therapy in the OnTarget trial. Our goal for the meeting is to discuss the most efficient pathway to make crofelemer available this patient population for cancer therapy-related diarrhea in the United States. And this is for the formulation currently known as I want to contrast this with what we were talking about in the rare disease program, which is a new formulation, a new product into a different business model. This is literally the same formulation of crofelemer as Mytesi currently on the is a unfortunately, a very common side effect of targeted cancer therapies. There's about 21 unmet needs in supportive care area for cancer treatment. And adjusting this supportive care is important not only for patient comfort and dignity as important as this are, but also diarrhea can lead to dose changes, treatment delays or often even cancellation, cessation of treatment altogether, which now is having an impact on the outcome of the patient's cancer treatment.I will now hand the over to Carol Lizak, our Chief Financial Officer for her recap of the financial highlights for the first quarter 2025. Carol, take it away. Carol Lizak Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the first quarter of 2025. The total net revenue for the company's prescription products, Mytesi, Gelclair and Canalevia-CA1, nonprescription products and license revenue was approximately $2.2 million in the first quarter of 2025 a decrease of approximately 6% versus the first quarter of 2024. Revenue of $2.4 million and 37% versus net fourth quarter 2024 revenue of $3.5 prescription volume increased by approximately 1.8% in the first quarter of 2025 over the first quarter of 2024 and decreased by approximately 13.5% in the first quarter of 2025 and over the fourth quarter of '24. Prescription volume differs from invoice sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory from operations increased by $1.2 million from $8.2 million in the quarter ended March 31, 2024 to $9.4 million during the same period in 2025. Non-GAAP recurring EBITDA for the first quarter of 2025 and 2024, were a net loss of $9.7 million and $8.8 million, respectively. Net loss attributable to common shareholders increased by approximately $1.2 million from $9.2 million in the quarter ended March 31, 2024 to $10.4 million in the same period in concludes my recap of high-level financials for the first quarter of 2025 and I will now hand the discussion back to Lisa Conte. Lisa Conte Thanks, Carol. So all members of Jaguar, Napo Pharmaceuticals, Napo Therapeutics in Italy, all of us in this family are energized and excited about the multiple expected near-term and recently completed catalysts throughout 2025 and beginning of 2026, all of which we view as important value-enhancing and potentially transformative for all our stakeholders, including, first and foremost, our catalysts, as I said, represent the convergence of key potential inflection points in our two major programs that have been in development for years, and we expect these catalysts to lead to important collaborations, business development and license deals and the opportunity to bring in nondilutive dollars to support these late-stage products and programs and get them to regulatory approval and reimbursed patient also another potential business development opportunity that I do want to mention. Our crofelemer product approved for chemotherapy-induced diarrhea in dogs use Canalevia-CA1 conditionally approved for chemotherapy-induced diarrhea in dogs the subject of business development conversations as well to support bringing the approval to include all noninfectious acute diarrhea in dogs. And it's really a very interesting situation at this time. If you are a patient in the United States with cancer and diarrhea, and you have 4 legs, we can educate and promote crofelemer as a dog, but not to a human, but not yet, and we're committed to make that we'll now play the recording for you of the fireside chat from the Elite Ped-Gi conference, which was the first of the really important catalysts for this year. It's about 12 minutes long. After the replay finishes, it will be the end of today's webcast. I will say my goodbyes and thank you and my gratitude for your participation at this I'll let you take it away and play the webcast. Operator This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.
