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Jaguar Health, Inc. (NASDAQ: JAGX) is a commercial-stage pharmaceuticals company specializing in the development of novel prescription medicines sustainably derived from natural plant sources in rainforest areas. The company's primary focus is on addressing gastrointestinal (GI) distress in both humans and animals, with an emphasis on chronic debilitating diarrhea and associated symptoms such as urgency, bowel incontinence, and cramping pain.
Jaguar Health operates through several subsidiaries, including Napo Pharmaceuticals, Inc., which develops and commercializes proprietary human GI pharmaceuticals globally. One of its flagship products, Mytesi® (crofelemer), is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The company’s lead animal prescription drug candidate, Canalevia™, targets forms of diarrhea in dogs, while Equilevia™ supports total gut health in equine athletes.
In addition, Jaguar Health, through its Napo Pharmaceuticals subsidiary, is advancing the development of crofelemer with the ongoing OnTarget study, a pivotal Phase 3 clinical trial aimed at the preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Crofelemer has also been designated an Orphan Drug by the FDA and European Medicines Agency for short bowel syndrome (SBS) and microvillus inclusion disease (MVID).
Jaguar Health’s commitment to cancer supportive care is showcased through its preparation to launch Gelclair®, an FDA-approved oral mucositis prescription product, in Q3 2024. This initiative is part of their broader strategy to support cancer patients facing severe treatment side effects.
Beyond GI distress, Jaguar Health has a joint venture called Magdalena Biosciences, in collaboration with Filament Health Corp. This venture focuses on developing plant-based prescription medicines for mental health indications. A recent out-licensing agreement with Magdalena includes a botanical drug candidate for potential schizophrenia and psychoses indications.
Jaguar Health’s financial performance reflects consistent growth, with Q1 2024 revenue at approximately $2.4 million, showing a 20% increase from Q1 2023. Despite operational losses, the company continues to invest in research and development, particularly for rare disease treatments.
For more information, visit Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics, and Magdalena Biosciences. Stay connected with Jaguar Health on LinkedIn, X (formerly Twitter), and Instagram.
Jaguar Health (NASDAQ:JAGX) is seeking a partner to develop and commercialize NP300, a second-generation antisecretory drug candidate for treating general diarrhea in dogs. NP300, derived from the Croton lechleri tree, has shown safety in dogs and shares similarities with Canalevia-CA1, the company's conditionally approved drug for chemotherapy-induced diarrhea. With approximately 6 million annual cases of acute and chronic diarrhea in dogs seen by U.S. veterinarians and no FDA-approved drugs for general canine diarrhea, the company aims to address this unmet need in the veterinary market.
Napo Therapeutics, a Jaguar Health family company, has been named 'Best Pharmaceuticals Innovator of the Year - Europe' by The European business publication. The company is advancing crofelemer, a novel oral plant-based prescription drug, for rare diseases in Europe.
The company is supporting proof-of-concept studies for microvillus inclusion disease (MVID) and short bowel syndrome (SBS) with results expected by end of 2024 and throughout 2025. Phase 2 trials for both conditions are planned to start before end of 2024. These studies could support early patient access to crofelemer in specific EU countries.
Jaguar Health (NASDAQ:JAGX) reported Q3 2024 financial results with combined net revenue of $3.1 million, showing a 14% increase from Q2 2024 ($2.7M) and 11% from Q3 2023 ($2.8M). The company's main product Mytesi saw revenue growth of 14% quarter-over-quarter to $3.0 million, with prescription volume up 10.9%. Despite revenue growth, the company reported a net loss of $9.9 million, increased from $7.8 million in Q3 2023. Operating loss improved to $7.3 million from $8.8 million year-over-year. The company announced progress in cancer supportive care trials and initiated commercial launch of Gelclair in October 2024.
Jaguar Health (NASDAQ:JAGX) has announced an upcoming investor webcast scheduled for Wednesday, November 13, 2024, at 8:30 AM Eastern Time. The webcast will review the company's third-quarter 2024 financial results and provide corporate updates. The company plans to file its Q3 2024 Earnings Report on Form 10-Q for the quarter ended September 30, 2024. A replay of the webcast will be available on Jaguar's investor relations website section.
Jaguar Health (NASDAQ:JAGX) announced FDA approval renewal for Canalevia-CA1, their prescription drug treating chemotherapy-induced diarrhea (CID) in dogs. The renewal extends conditional approval until December 21, 2025. Canalevia-CA1, a canine-specific formulation of crofelemer derived from the Croton lechleri tree, remains the first and only FDA-approved treatment for CID in dogs. The company is progressing toward full FDA approval through an agreed-upon clinical field study design. The drug is currently available through major U.S. veterinary distributors, including Chewy.
Jaguar Health (NASDAQ:JAGX) announced that a late-breaking abstract showing significant results for crofelemer in breast cancer patients from the Phase 3 OnTarget trial has been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The analysis focuses on breast cancer patients, who formed the majority of participants in this prophylactic trial studying cancer therapy-related diarrhea in adult patients with solid tumors. A second late-breaking abstract based on the trial's placebo arm data will also be presented. The company plans to use these findings to discuss potential pathways with the FDA for making crofelemer available to breast cancer patients.
Jaguar Health (NASDAQ:JAGX) announced positive results from two independent investigator-initiated studies of crofelemer, presented at the American College of Gastroenterology Annual Scientific Meeting. The first study showed that crofelemer significantly decreased stool consistency and abdominal pain in patients with functional diarrhea. The second study demonstrated that 58.8% of patients with chronic idiopathic diarrhea improved within a 4-week treatment period. Both studies suggest crofelemer's effectiveness in treating different forms of chronic diarrhea, with minimal side effects. The drug has also shown promise in previous Phase 2 trials for IBS-D and achieved statistical significance in breast cancer patients from the Phase 3 OnTarget trial.
Jaguar Health (NASDAQ:JAGX) has launched Gelclair, an FDA-approved oral mucositis prescription product, in the U.S. This marks Jaguar's third commercialized prescription product and initiates its commercial footprint in cancer supportive care. Gelclair is a gel that adheres to the mouth's mucosal surface, providing rapid and long-lasting pain relief without stinging or numbing.
Oral mucositis, affecting up to 90% of head and neck cancer patients treated with chemotherapy and radiotherapy, is a significant adverse event in oncology. It can lead to treatment interruptions and hospitalization. Jaguar's launch strategy includes a dedicated team of representatives and plans to exhibit at key oncology conferences.
Jaguar Health (NASDAQ:JAGX) has announced new employee inducement grants under Nasdaq Listing Rule 5635(c)(4). Effective October 7, 2024, the company granted restricted stock units (RSUs) to five new employees. New Employee 1 received 80,000 RSUs, which will vest equally over three years, with one-third of the shares vesting each year from the date of hire. New Employees 2-5 each received 15,000 RSUs, which will vest over one year from their respective hire dates.
These RSU grants were approved by Jaguar's Compensation Committee as an inducement for the employees to accept employment with the company. The vesting of the RSUs is contingent on each new employee's continued service with Jaguar through the applicable vesting dates.
Magdalena Biosciences, a joint venture between Jaguar Health and Filament Health, is set to present at the BIO Investor Forum on October 16, 2024. Dr. Karen Brunke, Jaguar's EVP and Acting CEO of Magdalena, will provide an overview of the company's progress in developing novel, natural prescription medicines for mental health indications.
Magdalena's lead botanical drug candidate, MB2500, is expected to be IND-enabled soon for attention deficit hyperactivity disorder (ADHD) and potentially for cognitive deficit in schizophrenia. The company aims to submit an Investigational New Drug (IND) application to the FDA in early 2025, with 1-2 additional IND applications planned for the same year.
MB2500 is derived from a well-characterized plant with neuroprotective and cognitive enhancing properties. Magdalena is focusing on advancing plant-based innovations for mental health conditions, targeting the $25 billion global ADHD market and the growing schizophrenia market, projected to reach $13.41 billion by 2032.
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