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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.
Napo Pharmaceuticals, a subsidiary of Jaguar Health (NASDAQ:JAGX), has received FDA activation for its Investigational New Drug (IND) application for NP-300, aimed at treating moderate-to-severe diarrhea due to cholera and other pathogens. This approval positions Napo to initiate a phase I clinical trial, following which it can progress to the next stages of development. NP-300, derived from Croton lechleri, could qualify for a Tropical Disease Priority Review Voucher, potentially yielding significant revenue upon approval. Cholera impacts millions globally, highlighting the drug's importance.
Jaguar Health, Inc. (NASDAQ:JAGX) announced that CEO Lisa Conte will present at the virtual Lytham Partners Fall 2022 Investor Conference on September 28, 2022, participating in a panel on orphan drugs. Conte expressed optimism regarding the potential clinical advancements for short bowel syndrome and congenital diarrheal diseases. Additionally, Jaguar will present at the Ladenburg Thalmann 2022 Healthcare Conference on September 29, 2022. The company focuses on therapies for rare diseases, with a significant emphasis on their crofelemer product.
Jaguar Health (NASDAQ:JAGX) announced the IND application submission for NP-300, aimed at treating diarrhea from cholera. This initiative follows their prior Phase 2 findings on crofelemer, which shares a similar mechanism. The company plans to pursue a Tropical Disease Priority Review Voucher post-approval, which has previously commanded values up to $350 million. Jaguar is also focusing on pivotal clinical trials, including a Phase 3 trial for cancer therapy-related diarrhea, expected to complete enrollment by mid-2023. The cholera indication aligns with significant global health needs.
Jaguar Health, Inc. (NASDAQ:JAGX) announced a royalty interest purchase agreement with Streeterville Capital, securing $4.0 million. This capital will support the ongoing pivotal Phase 3 OnTarget trial of crofelemer for preventing diarrhea in adults undergoing cancer treatment. Streeterville will receive three times the royalty purchase price from future sales royalties and milestone payments. Jaguar anticipates key development milestones within the next 6-12 months, including expediting enrollment in the OnTarget trial and a proof-of-concept study for short bowel syndrome (SBS).
Jaguar Health (NASDAQ:JAGX) announced that the FDA accepted its orphan drug designation application for crofelemer to treat Microvillus Inclusion Disease (MVID), a rare genetic disorder affecting newborns. A response is expected by the end of September 2022. In Q2 2022, Mytesi net revenue reached approximately $2.9 million, a 12% increase from Q1 2022 and a 641% rise from Q2 2021. The company credits improved revenue to a shift to a closed network of specialty pharmacies. Napo Therapeutics submitted a similar application to the EMA, focusing on expanding crofelemer access in Europe.
Jaguar Health reported a strong Q2 2022 performance with $2.9 million in prescription product net revenue, a 12% increase quarter-over-quarter and a remarkable 641% rise year-over-year. The growth is attributed to a transition to a limited distribution network, reducing costs and enhancing Mytesi's gross-to-net ratio. Key initiatives include the ongoing OnTarget Phase 3 clinical trial for crofelemer and expected results from an investigator-initiated study for short bowel syndrome soon. Canalevia-CA1 for dogs also launched, showing promises in the veterinary market.
Jaguar Health (NASDAQ:JAGX) received a 180-day grace period from Nasdaq to regain compliance with the $1.00 bid price requirement, extending the deadline to February 13, 2023. To maintain its listing, Jaguar must achieve a closing bid price of at least $1.00 for ten consecutive business days. The company is focusing on two pivotal clinical activities in the next 6 to 12 months: a proof-of-concept study for crofelemer targeting short bowel syndrome and a Phase 3 trial for cancer therapy-related diarrhea, with expectations of significant value creation.
Jaguar Health, Inc. (NASDAQ:JAGX) will host an investor webcast on August 22, 2022, at 8:30 AM Eastern Time to present its second-quarter 2022 financial results and corporate updates. The company plans to file its Earnings Report on Form 10-Q for the quarter ended June 30, 2022. Jaguar Health focuses on developing plant-based, non-opioid medications for gastrointestinal distress in both humans and animals. For more details and to register for the webcast, visit this link.
Jaguar Health has appointed Dr. Anula Jayasuriya to its Board of Directors as of July 1, 2022. With extensive experience in healthcare and investment, her expertise is expected to enhance Jaguar's efforts in gastrointestinal medicine development. The company also established a Business Development Advisory Committee, chaired by Rachel Zolot Schwartz, to explore partnerships and acquisitions. These strategic moves aim to strengthen Jaguar's market position and drive growth for its plant-based products, particularly crofelemer.
Jaguar Health (NASDAQ:JAGX) granted 60,000 restricted stock units (RSUs) to New Employee 1 and 12,500 RSUs to New Employee 2 as an inducement for their employment effective June 27, 2022. The RSUs for New Employee 1 will vest fully after one year, while those for New Employee 2 will vest equally over three years. This initiative was approved by the Compensation Committee and is contingent on the employees' continued service with Jaguar. The company focuses on developing sustainable, plant-based medicines for gastrointestinal distress.
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