Mr. Stephen Van Deventer reports

PREVECEUTICAL & ENDOSANE ANNOUNCES INNOVATIVE PRECLINICAL APPROACHES TO ASSESS BRAIN AVAILABILITY OF CBD AND PHARMACOLOGICALLY RELEVANT DOSES FOLLOWING INTRANASAL CBD APPLICATION

Preveceutical Medical Inc. and Endosane Pharmaceuticals GmbH will proceed with the company's research initiative focused on preclinical studies to evaluate the brain delivery characteristics of sol-gel technology and whether pharmacologically relevant concentrations of CBD (cannabidiol) can be achieved with this technology. The company's commitment to advancing medical research is demonstrated through its comprehensive research proposal for a first preclinical study in rats.

Research Objectives:

The primary objectives of this study include:

Objective 1: Investigating the potential of sol-gel technology for rapid delivery of CBD to the brain. This includes assessing the amounts achieved, regional distribution, and time course of CBD uptake in the brain (Experiments 1 and 2).

Objective 2: Demonstrating the pharmacological relevance of brain CBD concentrations following intranasal application (Experiment 3).

Study Design:

The research will be conducted through a series of well-structured experiments:

Experiment 1: Rats will be administered up to three doses of CBD in sol-gel form via nasal spray. Evaluation will be carried out at six different time points. Brain regions such as the olfactory bulb, prefrontal cortex, parietal cortex, pons, and cerebellum will be assessed, and concentrations of CBD and its metabolites will be quantified using a validated LC-MS/MS assay.

Experiment 2: A separate group of rats will receive intranasal CBD administration. Cerebrospinal fluid (CSF) and cardiac blood samples will be collected at specific time points based on the findings from Experiment 1. CBD and metabolite concentrations will be measured using validated LC-MS/MS assays.

Experiment 3: Building upon the outcomes of Experiment 1, the study will assess intranasal CBD doses that yield significant brain exposure in rat models of anxiety and chronic pain. These are two conditions in which CBD has already demonstrated preclinical efficacy.

Collaborative Efforts:

Endosane is collaborating closely with the Brain and Mind Centre of the University of Sydney. A significant breakthrough in this partnership has been the identification of anandamide as a potential blood surrogate marker for CBD's brain activity. The research team has also examined the temporal changes in serum.

PreveCeutical and Endosane dedication to research in the field of CBD delivery and pharmacology underscores its commitment to advancing medical knowledge and improving patient outcomes. The company remains focused on scientific innovation, working diligently to pave the way for novel treatments and therapies.

About Endosane

Endosane Pharmaceuticals GmbH, a joint venture between an international team of scientists and the Berlin-based health and life science company Sanity Group, develops finished medicinal products for the treatment of neuropsychiatric and psychiatric disorders. To this end, Endosane Pharmaceuticals is systematically researching the endocannabinoid system for its potential to modulate neurophysiological balance. The current drug portfolio contains compounds for the treatment of various indications, including schizophrenia, social anxiety disorder and post-traumatic stress disorder. The international team is led by the renowned German neurologist and psychiatrist Prof. Dr. F. Markus Leweke (University of Sydney), long-time head of the Center of Excellence for Psychiatry and Psychotherapy Research at the Central Institute of Mental Health Mannheim at the Ruprecht-Karls-University Heidelberg. The company, founded in 2020, is based in Berlin. More information at www.endosane.com.

About the Sanity Group

Sanity Group has set itself the goal of improving the quality of life of people through the sensible use of cannabinoids and the use of the endocannabinoid system. In addition to pharmaceuticals, it also focuses on well-being and cosmetic products based on cannabinoids. In parallel, Sanity Group is working and researching new medical products, innovative dosage forms, as well as technological products and services to further develop the infrastructure. Sanity Group was founded in 2018 by Finn Age Hansel and Fabian Friede and now employs a team of over 100 people at its headquarters in Berlin-Mitte and its research site near Frankfurt am Main. Sanity Group brands include Vayamed (pharmaceuticals), VAAY (CBD products) and This Place (functional cosmetics). More information at www.sanitygroup.com.

About PreveCeutical

PreveCeutical is a health sciences company that develops innovative options for preventive and curative therapies utilizing organic and nature identical products. The Company aims to be a leader in the preventive health sciences sector.

With the completion of three of its research programs, the Company is actively working on the development, clinical trials, and commercialization of its products; and has filed a number of provisional patent applications to protect the intellectual property from its research programs.

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