Anorexia Nervosa

Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ADHD and schizophrenia, with 1-2 additional IND applications filed in late 2025/early 2026 SAN FRANCISCO, CA / ACCESS Newswire / February 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Dr. Karen Brunke, Jaguar's EVP of Corporate and Business Development and Acting CEO of 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, is presenting in person on Monday, February 10, 2025 at 2:30 PM Eastern at the BIO CEO & Investor Conference in New York City. "I very much look forward to providing an overview of Magdalena at this conference and meeting with potential partners and investors at this event," Dr. Brunke said. "We expect Magdalena's lead botanical drug candidate, MB2500, to soon be IND-enabled for one of the following indications: cognitive deficit in schizophrenia or executive dysfunction in attention deficit hyperactivity disorder (ADHD). MB2500 may have the potential to serve as a first-ever treatment for the cognitive deficit that goes untreated in schizophrenia, which is a huge unmet medical need. Schizophrenia is a disease of cognitive deficit, a deficit which appears as much as a decade before onset of psychotic symptoms,1 but no approved drug currently exists to treat cognitive deficit in schizophrenia patients." MB2500 is derived from a well characterized plant that has been in use by local populations for centuries, and has been shown to have both neuroprotective and cognitive enhancing properties, but has never been put through the rigorous clinical testing required for FDA approval. One or two more Magdalena botanical drug candidates for mental health indications are planned to be IND-enabled in late 2025/early 2026. ADHD, a $25 billion global market,2 is a neurodevelopmental disorder characterized by the core symptoms of hyperactivity, inattentiveness, and impulsivity, and there is a growing need for safer ADHD treatments. Schizophrenia is a chronic, disabling mental illness that affects approximately one percent of the U.S. population.3 The global schizophrenia market is projected to grow to $13.41 billion by 2032, according to a market research report by Market Research Future.4 The mission of Magdalena, which is currently approximately 40-percent owned by Jaguar, is to develop novel, safe, efficacious next-generation psychoactive FDA-approved plant-based drugs under FDA Botanical Guidance for mental health indications including schizophrenia, anxiety, depression, and ADHD. Botanical drug candidates have a long history of use by traditional psychiatrists and may have the potential to serve as a new class of plant-based psychoactive drugs which are safe for daily dosing. "Our approach is paradigm-shifting in drug development as we expect to go from plant extract to proof-of-concept (POC) human studies in 12-24 months - a huge time and cost savings which also, based on the history of human medicinal use of the plants, has a higher probability of success," said Dr. Brunke. 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, botanical 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. The Growing Market for Medicines Derived from Psychoactive Plants According to the World Health Organization, one in four people in the world will be affected by mental or neurological disorders at some point in their lives. Around 450 million people currently suffer from such conditions, placing mental disorders among the leading causes of ill-health and disability worldwide. Among children, ADHD is the most common psychiatric disorder, disrupting learning and social behaviors. Common mental health conditions include depression, PTSD, anxiety, addiction, bipolar disorder (formerly called manic-depressive illness or manic depression), and anorexia nervosa, and expand to include neuro-degenerative diseases such as Parkinson's, Alzheimer's disease, and ALS (amyotrophic lateral sclerosis), among others. Substance use disorders occur when the recurring use of alcohol and/or drugs causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, home, or school. The Lancet Commission, a group of experts in neuroscience, psychiatry, public health, and related fields, estimates that the cost of mental disorders, currently on the rise in every country, will reach $16 trillion by 2030, including costs associated with lost productivity. 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. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates. Learn more at www.filament.health and on Twitter, Instagram 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 (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 Magdalena management will present at the 2025 BIO CEO & Investor Conference, the expectation that MB2500 will soon be IND-enabled and ready to enter the clinic for the first of two indications, the expectation that MB2500 may have the potential to serve as a first-ever treatment for the cognitive deficit that goes untreated in schizophrenia, the expectation that Magdalena may submit an IND application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as schizophrenia and ADHD, the expectation that 1-2 more additional Magdalena botanical drug candidates for mental health indications may be IND-enabled in late 2025/early 2026 and submitted as IND applications in late 2025/early 2026, the expectation that MB2500 may have the potential to be an effective treatment for ADHD or the cognitive deficit in schizophrenia, the expectation that botanical drug candidates may have the potential to serve as a new class of plant-based psychoactive drugs which are safe for daily at-home dosing, Magdalena's expectation that Magdalena may be able to go from plant extract to POC human studies within 12-24 months, and the expectation that human studies of Magdalena botanical drug candidates may have a higher probability of success based on the history of human medicinal use of the Magdalena botanical drug candidates. 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 JAMA Psychiatry. 2013;70(10):1107-1112. doi:10.1001/jamapsychiatry.2013.155 2 https://finance.yahoo.com/news/attention-deficit-hyperactivity-disorder-adhd-220000543.html 3 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 4 https://www.marketresearchfuture.com/reports/schizophrenia-market-1625 Contact Info: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.

LONDON & NEW YORK--( BUSINESS WIRE )--Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced the appointment of Steve Levine, M.D., as Chief Patient Officer, effective immediately. In this newly developed executive team role, Dr. Levine will be responsible for ensuring that patient-centric strategies are embedded across the organization and that treatments and initiatives developed by the company are focused on addressing unmet needs in current clinical care and are designed to improve patient outcomes. “Steve has spent the past four years working to deeply understand barriers to care for patients living with serious mental health conditions and he is committed to helping find solutions to address those barriers,” said Kabir Nath, CEO of Compass Pathways. “Steve shares a passion for our mission to bring better options to people who urgently need them, and I am delighted to welcome him onto the executive leadership team and into the newly developed Chief Patient Officer role.” Dr. Levine has been a member of the Compass team since 2020, serving as Senior Vice President of Patient Access. Dr. Levine is a board-certified psychiatrist who has spent his career working across multiple facets of the healthcare system to improve people’s lives through creating access to innovation. Dr. Levine completed his internship and residency in psychiatry at New York - Presbyterian Hospital/Weill Cornell Medical Center. He then completed a fellowship subspecialty training in psychosomatic medicine/psycho-oncology at Memorial Sloan Kettering Cancer Center/New York - Presbyterian Hospital. Prior to Compass, he led the company he founded in 2010, Actify Neurotherapies, that built new models of care delivery across the US for interventional psychiatry treatments. He has published extensively in both peer-reviewed journals and popular media, presented to both professional and lay audiences around the world, served in leadership roles for professional societies and not-for-profit entities, and received numerous awards for leadership and service. Dr. Levine is also an adjunct professor at Rutgers Medical School. Offering congratulations to Dr. Levine on his expanded role as Chief Patient Officer at Compass Pathways, Debbie Plotnick, Executive Vice President for State and Federal Advocacy at Mental Health America (MHA), stated, “Listening to people impacted by mental health conditions and prioritizing their needs and desires for new types of therapies, and working to assure access to them, are shared core values of Compass and MHA." “I've spent my career pursuing better outcomes and experiences for those living with serious mental health conditions. At Compass, I believe we have an opportunity to transform lives by creating, and making accessible, truly new options," said Dr. Levine. “I am excited about the opportunity that I have in this new role to help transform patient care.” About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding the impact of executive team appointments; the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for mental health conditions, including TRD, PTSD or anorexia nervosa; the potential for the pivotal phase 3 program in TRD or other trials to support regulatory filings and approvals; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment . The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage executive team changes and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov . Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof.

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from an exploratory Phase 2A study of PH284 in cancer cachexia. PH284 is an investigational pherine nasal spray differentiated from all current treatments for the loss of appetite associated with chronic disorders, such as cancer. In the study, PH284 demonstrated higher mean subjective feeling of hunger as compared to placebo and appeared safe and well-tolerated with an adverse event profile similar to placebo in a population compromised by terminal cancer. “We are highly encouraged by the potential of PH284 to improve the quality of life for those challenged by the debilitating impacts of cancer cachexia,” stated Shawn Singh, President and Chief Executive Officer of Vistagen. “Loss of appetite from cancer and other illnesses not only negatively impacts overall health and quality of life, but can also reduce the effectiveness of critical therapies, such as chemotherapy in cancer patients. PH284 is our fifth novel investigational pherine, each supported by positive Phase 2 or later clinical data and placebo-like tolerability, underscoring the breadth, diversity and potential of our neuroscience pipeline to address multiple significant unmet needs.” The previously unreported double-blind, placebo-controlled exploratory Phase 2A study was designed to evaluate the efficacy, safety, and tolerability of intranasal administration of PH284 in female patients diagnosed with cachexia (induced by chronic loss of appetite) due to terminal cancer (n=40). PH284 nasal spray (0.4 µg/50 µL) was administered intranasally, one spray in each nostril (total daily dose = 3.2µg), four times daily before meals (breakfast, mid-morning snack, lunch, and dinner). From Day 1 through Day 4, all subjects were administered placebo 30 minutes prior to each meal. Beginning on Day 5 through Day 11 subjects were randomized in a 1:1 fashion to receive either PH284 or placebo. Efficacy Patients measured Subjective Feeling of Hunger (SFH) ten minutes before each meal. PH284, as compared to placebo, induced a cumulative effect on mean SFH scores, with scores increasing from breakfast to lunch and lunch to dinner throughout the treatment period. Specifically, prior to dinner on Day 7 of treatment, PH284 subjects reported a 71% improvement in SFH versus baseline, while placebo subjects reported a less than 1% improvement. Safety and Tolerability No unusual changes in body weight were observed in either the PH284 or placebo groups, though on average, there was a small gain in body weight for PH284 versus a small loss in placebo. PH284 demonstrated no serious adverse events, and adverse events reported for the PH284 group were similar to those reported in the placebo-treated group. All the adverse events reported were attributed to the underlying medical condition (cancer) and were not deemed to be related to the administration of PH284 or placebo. About Cachexia Cachexia, also known as wasting syndrome, is a complex metabolic syndrome that causes a gradual loss of muscle and body weight. Cachexia is associated with chronic diseases like cancer, AIDS, heart failure, chronic obstructive pulmonary disease (COPD), anorexia nervosa, multiple sclerosis, tuberculosis, and anemias. The current definition of cancer cachexia is a loss of 5% or more of body weight over the preceding six months, accompanied by any of a handful of other symptoms, including fatigue and reduced strength. According to the National Cancer Institute, cachexia is estimated to occur in up to 80% of people with advanced cancer, depending on the type of cancer and how well they respond to cancer treatment. Cachexia is thought to directly cause up to 30% of cancer deaths, often because of heart or respiratory failure related to muscle loss. Maintaining nutritional support and alleviating cachexia has the potential to improve the underlying condition of cancer. Currently, there are no effective medical interventions or approved drugs proven to alleviate cachexia. This previously unreported Phase 2A exploratory study of PH284 was sponsored by Pherin Pharmaceuticals (Pherin), now a wholly owned subsidiary of Vistagen, and conducted at the National Institute of Oncology (INCAN) and National Institute of Nutrition (INNSZ) in Mexico City, Mexico, in 2005. Vistagen gained access to the results of this study in connection with its acquisition of Pherin in February 2023. Hector Burges, MD, former Director, Institute of Nutrition; Marcos Cano Guardiana, MD, Associate Professor, National Institute of Oncology, Mexico City; and Ricardo Plancarte Sanchez, MD, Head of the Pain Clinic, Institute of Oncology, Mexico City, served as the Principal Investigators of the study. About PH284 PH284 is an investigational neuroactive pherine nasal spray with a novel, rapid-onset potential mechanism of action (MOA) that is fundamentally differentiated from the MOA of all current treatments for the loss of appetite associated with chronic disorders, such as cancer or heart disease. PH284 is thought to act by regulating olfactory to mediobasal-hypothalamus neural circuits involved in appetite control. PH284 has demonstrated an excellent safety profile in all clinical trials completed to date. Vistagen is currently evaluating the potential path forward for PH284, including an assessment of completed studies and studies we believe are necessary to support a U.S. Investigational New Drug application for potential further Phase 2 clinical development of PH284 for the treatment of cachexia. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.Vistagen.com . Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual timelines, results or development may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that PH284, or any of Vistagen’s product candidates, will successfully replicate past clinical trials, complete ongoing or future clinical trials within the timeframe estimated by Vistagen or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching, conducting and/or completing ongoing and planned clinical trials; the availability and scope of applicable patents; fluctuating costs of materials and other resources and services required to conduct Vistagen’s ongoing and/or planned clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen’s product candidates. These risks are more fully discussed in the section entitled "Risk Factors" in Vistagen’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen’s SEC filings are available on the SEC’s website at www.sec.gov . Additionally, you should not place undue reliance on these forward-looking statements in the future, because they apply only as of the date of this press release and should not be relied upon as representing Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.