Jaguar Health Executes Out-License Deal with Joint Venture Magdalena Biosciences for Botanical Drug Candidate for Schizophrenia

Rhea-AI Summary

Jaguar Health has announced an out-licensing agreement with Magdalena Biosciences for a botanical drug candidate aimed at treating schizophrenia. This drug shows antipsychotic activity with a unique mechanism of action compared to current FDA-approved therapies. Under the deal, Jaguar will receive 10% of all upfront and milestone payments, excluding certain commercial milestones and R&D reimbursements. Additionally, Jaguar will earn royalties on net sales if the drug is FDA-approved and commercialized. The U.S. schizophrenia market is forecasted to reach $8.06 billion by 2030. Jaguar will present at the Lytham Partners Spring 2024 Investor Conference on May 30.

Positive

• Jaguar Health will receive 10% of upfront and milestone payments from the deal.
• The company will earn royalties on net sales if the drug is approved and commercialized.
• The U.S. schizophrenia market is projected to hit $8.06 billion by 2030.
• The drug candidate shows unique antipsychotic activity distinct from existing FDA therapies.
• Participation in the Lytham Partners Spring 2024 Investor Conference could attract investor interest.

Negative

• Jaguar's earnings are dependent on the successful FDA approval and commercialization of the drug.
• The company will not receive payments related to commercial milestones and R&D reimbursements.
• Approximately 34% of schizophrenia patients do not respond to existing treatments, which could also impact the new drug.

Insights

Financial Analyst

The out-licensing agreement between Jaguar Health and Magdalena Biosciences could have significant financial implications for Jaguar Health. By securing 10% of all upfront and milestone payments, Jaguar stands to benefit from any successful business development partnerships involving the Botanical Drug Candidate. Additionally, the increasing royalty structure based on annual net sales, if the drug candidate receives FDA approval, provides a scalable revenue opportunity. Given the projected growth of the U.S. schizophrenia market to $8.06 billion by 2030, the potential financial upside for Jaguar could be substantial.

However, there are inherent risks. The drug candidate is still in development and must successfully navigate clinical trials and obtain FDA approval, a process fraught with uncertainty. Investors should weigh the potential lucrative returns against these risks.

Medical Research Analyst

The Botanical Drug Candidate's unique mechanism of action, distinct from currently FDA-approved therapies, presents a promising alternative for treating schizophrenia and other mental conditions with psychotic symptoms. Given that up to 34% of schizophrenia patients do not respond to existing treatments, this new approach could address a significant unmet medical need. The use of ethnobotanical knowledge and traditional medicinal plants adds a novel dimension to drug development, potentially bringing first-in-class plant-based antipsychotic treatments to the market.

Nevertheless, the efficacy and safety of the Botanical Drug Candidate must be validated through rigorous clinical trials and the novelty of its mechanism could present unknown challenges. Investors should be mindful of the lengthy and costly nature of drug development and regulatory approval processes.

The drug candidate demonstrates antipsychotic activity and has a mechanism of action distinct from FDA-approved therapies for schizophrenia and other mental conditions that present psychotic symptoms

Jaguar to receive percent of milestone payments and increasing royalties upon commercialization into the U.S. schizophrenia market, which is estimated to reach $8.06 billion by 2030

Jaguar to present May 30 at Lytham Partners Spring 2024 Investor Conference. Click here to register for conference.

SAN FRANCISCO, CA / ACCESSWIRE / May 29, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the company's out-licensing agreement with Magdalena Biosciences, Inc. ("Magdalena"), the joint venture formed by Jaguar and Filament Health Corp. (OTCQB:FLHLF)(CBOE CA:FH)(FSE:7QS) to develop novel, natural prescription medicines derived from plants for mental health indications, has been expanded to cover ethnobotanical know-how related to development of a prescription drug compound (the "Botanical Drug Candidate") from a specified medicinal plant for possible schizophrenia and psychoses indications and for development with potential corporate partners.

"We are very happy to have executed the out-licensing arrangement with Magdalena related to the Botanical Drug Candidate," said Lisa Conte, Jaguar's president and CEO. "The amended license agreement between Jaguar and Magdalena stipulates that Jaguar will receive 10% of all upfront payments, milestone payments, and similar payments received by Magdalena as part of any business development partnerships Magdalena enters for the Botanical Drug Candidate, excluding commercial milestones and R&D reimbursements, up to a defined cap amount. The amended license agreement also stipulates that Jaguar will receive royalties on annual net sales of the Botanical Drug Candidate by Magdalena and any sublicensees, if the Botanical Drug Candidate receives FDA approval and is commercialized, with the royalty percentage increasing if annual net sales surpass a defined dollar amount."

The U.S. schizophrenia market is projected to grow to $8.06 billion by 2030, according to a market research report by Market Research Future.¹

Neuropsychopharmacology profile analysis shows the Botanical Drug Candidate demonstrates antipsychotic activity and has a mechanism of action distinct from FDA-approved therapies for schizophrenia and other mental conditions that present psychotic symptoms. Magdalena, which is approximately 40-percent owned by Jaguar, is focused on advancing plant-based innovation for patients and on identifying the next generation of plant-based first-in-class agents for treatment of mental health conditions. The Botanical Drug Candidate has a long history of use by traditional healers and may have the potential to be the first in a new class of plant-based antipsychotic compounds.

"Our team has always recognized and valued the unique and powerful knowledge Indigenous and traditional peoples have about plants, ecosystems, and healing compounds," said Steven King, Ph.D., Jaguar's chief sustainable supply and ethnobotanical research officer and an Advisor to Magdalena. "Jaguar's library of approximately 2,300 medicinal plants from tropical regions - developed over three decades by medicinal tropical scientific strategy team advisors, including ethnobotanists, physicians, pharmacologists, chemists, and experts in neuropharmacology from around the world - comprises a unique asset to drive drug discovery. The plant collection was assembled by teams of experts who conducted primary, first-hand field investigations and plant identification work in rainforest regions around the globe in addition to gathering data about traditional medicinal uses of plants from shamans and other Indigenous healers."

Schizophrenia, the most serious form of psychosis, is a chronic, disabling mental illness that affects approximately one percent of the U.S. population.² It is estimated that up to 34% of patients with schizophrenia fail to respond to currently available treatments.³ Psychotic symptoms can also be present in other mental illnesses, including depression, bipolar disorder, dementia, and borderline personality disorder.

Jaguar to Participate in Lytham Partners Spring 2024 Investor Conference on May 30^th

Jaguar will participate in a webcasted presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2024 Investor Conference, taking place virtually on Thursday, May 30, 2024.

The webcasted presentation will take place at 2:00 pm Eastern on Thursday, May 30, 2024. The webcast can be accessed by visiting the conference home page at https://lythampartners.com/spring2024/ or directly at https://wsw.com/webcast/lytham11/jagx/2085930. The webcast will also be available for replay following the event.

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×1@lythampartners.com or register for the event at https://lythampartners.com/spring2024invreg/.

About Botanicals Drugs

Botanicals drugs are defined by the U.S. Food and Drug Administration (FDA) as "products from plant materials, algae, macroscopic fungi, and combinations thereof." Many botanical drugs have a long history of safe use in traditional medicines, which may be documented and reviewed in scientific literature. Existing scientific literature on safety may accelerate the safety review process for a botanical drug, reducing the scope and financial burden for extensive safety studies. The FDA has established guidance on botanical drug development and recognizes the complexity of botanical drugs. Additionally, botanicals drugs, by virtue of their complexity, have the added benefit of being difficult to genericize. Hence there are often multiple opportunities for creating ‘trade-secrets,' as well as novel patents around a botanical drug substance, its processing, its formulation, and so forth.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF)(CBOE CA:FH)(FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter and LinkedIn.

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 Jaguar will receive 10% of all upfront payments, milestone payments, and similar payments received by Magdalena as part of any business development partnerships Magdalena enters for the Botanical Drug Candidate, excluding commercial milestones and R&D reimbursements, up to a defined cap amount, the expectation that Jaguar will receive royalties on annual net sales of the Botanical Drug Candidate by Magdalena and any sublicensees if the Botanical Drug Candidate receives FDA approval and is commercialized, the expectation that the Botanical Drug Candidate may have the potential to be the first in a new class of plant-based antipsychotic compounds, and the expectation that Jaguar will participate in the Lytham Partners Spring 2024 Investor Conference on May 30, 2024. 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.marketresearchfuture.com/reports/schizophrenia-market-1625

² Bromet EJ, Dew MA, Eaton W. Epidemiology of psychosis with special reference to schizophrenia. In: Tsuang MT, Tohen M, Zahner GEP, eds. Textbook in psychiatric epidemiology. New York: John Wiley, 1996:283-300

³ Demjaha, A. et al. Antipsychotic treatment resistance in first-episode psychosis: prevalence, subtypes and predictors. Psychol. Med 47, 1981-1989 (2017); Lally, J. et al. Two distinct patterns of treatment resistance: clinical predictors of treatment resistance in first-episode schizophrenia spectrum psychoses. Psychol. Med 46, 3231-3240 (2016); Meltzer, H. Y. et al. Age at onset and gender of schizophrenic patients in relation to neuroleptic resistance. Am. J. Psychiatry 154, 475-482 (1997).

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on accesswire.com

FAQ

What is Jaguar Health's new agreement about?

Jaguar Health has signed an out-licensing deal with Magdalena Biosciences for a botanical drug candidate for schizophrenia.

What percentage of payments will Jaguar Health receive under the new deal?

Jaguar Health will receive 10% of all upfront and milestone payments from the deal.

When will Jaguar Health present at the Lytham Partners Spring 2024 Investor Conference?

Jaguar Health will present on May 30, 2024, at the Lytham Partners Spring 2024 Investor Conference.

What is the projected market size for schizophrenia treatments in the U.S. by 2030?

The U.S. schizophrenia market is projected to reach $8.06 billion by 2030.

What makes Jaguar Health's botanical drug candidate unique?

The drug candidate has antipsychotic activity and a mechanism of action distinct from FDA-approved therapies.