Palm Beach, FL – June 15, 2021 – The modern psychedelic renaissance has empirically proven that psychedelic drugs are going to revolutionize mental health treatment. Before these incredibly promising medicines can get to the people who need them the most, they must pass through the extensive drug development pipeline, where IP & Patents are crucial. It seems that a week doesn’t go by without a psychedelic company saying it has filed for a new patent. An informative article on Microdose explains the reasons why psychedelic companies are pursuing these patents. First, the plants that the medicines are based on can’t be patented. Products in nature belong to the public and thus can’t be patented. Microdose wrote, “One company cannot claim it as intellectual property to exclusively profit from it. However companies can “create new molecules based on natural psychedelics to create an improved drug. These new, altered molecules are patentable and provide the necessary framework to create new and focused treatments for different neurological and psychological health conditions from their natural predecessors. If a company can get the patent, then it allows the treatment to be developed.”   Active companies in news today include:  Nextleaf Solutions Ltd. (OTCQB: OILFF) (CSE: OILS), MindMed (NASDAQ: MNMD), Numinus Wellness Inc. (OTCPK: LKYSF)  (TSX-V: NUMI), Field Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP), Cardiol Therapeutics Inc. (OTCQX: CRTPF) (TSX: CRDL).

Microdose article continued with “Without patents, competitors could easily duplicate the manufacturing of a drug and there would be no incentive for anyone to create these new treatments. Many of these companies are filing for provisional patents. These applications are issued by the U.S. Patent and Trademark Office (USPTO) and it helps to protect a new invention from being copied during the 12-month period before a formal patent application is filed. The idea is that it gives a company to test or refine a product before committing to the expensive and time-intensive process of a formal application.  In more mature markets, filing for patents would be a nonevent but since psychedelics are so new, these are worth watching. There is clearly a land grab for application processes as well as formulations. While some of it feels like these companies are casting a wide net, it surely makes sense to be creative and file now at the beginning of the mushroom mania… This is an incredible opportunity for advanced and innovative drug developers to create novel psychedelic drugs that can offer massive benefits beyond traditional psychedelic drugs. However, this pathway requires significant capital, time and skill. Patenting is one of the most important steps to bringing a new drug to market.”

One of the Companies in play in this exploding market is Nextleaf with its 80 issued global patents, which is using its proven track record to explore more complex cannabinoid-based treatments for development of psychedelic therapies and treatments.

Nextleaf Solutions Ltd. (OTCQB: OILFF) (CSE: OILS) BREAKING NEWS – Nextleaf Launches Specialty Molecules Division – THC-O-Acetate to be Produced Through Company’s Specialty Molecule Division –  Nextleaf Solutions Ltd. (“Nextleaf“, “OILS“, or the “Company“), an extraction company that owns one of the largest portfolios of U.S. patents for the extraction and distillation of cannabinoids, is pleased to announce the launch of a Specialty Molecules Division to focus on the development and commercialization of novel and psychedelic molecules. The division is supported by the Company’s existing intellectual property portfolio, including the manufacturing of CBD-O-acetate and the recently announced U.S. Patent for the synthesis of THC-O-acetate.

“The purpose of this new division is to leverage Nextleaf’s existing intellectual property and delivery technology to develop IP protected therapeutic products from novel molecules,” said Paul Pedersen, Chief Executive Officer of OILS. “The commercial opportunity for our Speciality Molecules Division is to partner with larger organizations looking for differentiation by leveraging Nextleaf’s intellectual property and Metro Vancouver based licensed innovation lab and extraction plant to manufacture speciality molecules under our Health Canada licenses. We anticipate our Specialty Molecules Division will play a major role in the long-term value creation thanks to the disruptive nature of our acetylation IP,” said Pedersen.

There is increased focus and investment from large cannabis and pharma companies in novel cannabinoid-based products with wellness and therapeutic applications. An example is British American Tobacco’s recent $221 million investment in Organigram. The Company expects to announce a future R&D and innovation agreement with a large strategic partner operating in the cannabis and pharmaceutical space.

The initial focus of the Specialty Molecules Division is commercializing more complex cannabinoid-based treatments that may provide an alternative to opioid based medications. The Company currently holds the prerequisite licensing necessary under the Cannabis Act to commercialize THC-O-acetate in Canada.

THC-O-Acetate – Nextleaf intends to develop therapeutic products from its intellectual property pertaining to the acetylation of cannabinoids. The Company expects to release adult-use products with THC-O-acetate, which to the best of the Company’s knowledge has never been sold under a legal framework.

The Company believes a THC-derived product produced with its patented acetylation process may hold significant potential as a therapeutic due to THC-O-acetate reportedly having pronounced psychedelic effects compared to delta-9-THC, and positive outcomes in the treatment of cancer, chronic pain, PTSD, and alcohol use disorder.

Nextleaf’s U.S. and Canadian issued patents describe a process of acetylating THC by refluxing naturally derived THC distillate in the presence of a single reactant, with THC-O-acetate the product of the reaction.

“This U.S. patent covers our method of THC acetylation and follows our previous patent for synthesizing THC-O-acetate, with improvements to reaction efficiencies,” said patent author Dr. David Novitski. “Our latest patented method reduces processing time and costs, which are critical when scaling up any drug delivery technology, and THC-O-acetate is no different.”  CONTINUED…  Read this and more news for Nextleaf Solutions by visiting:  https://www.nextleafsolutions.com/press-releases/    

In other industry news of note:

MindMed (NASDAQ: MNMD), a leading psychedelic medicine biotech company, recently announced the publication of the first pharmacogenetic data on LSD to help personalize dosing. The study results from a pooled secondary analysis of four Phase 1 studies that each used a randomized, double-blind, placebo-controlled, crossover design and were conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

The results of this study indicate that pharmacogenetic testing prior to LSD-assisted treatment may inform LSD dose selection at the individual patient level.  Dr. Matthias Liechti said, “This is the first data on the pharmacogenetics of LSD. The results indicate that a test of the metabolic function of a patient by CYP2D6 phenotyping and genotyping can be used to adjust the dose of LSD. Such information is important for the further development of LSD into a medication and could ultimately help to personalize patient treatment.”

Numinus Wellness Inc. (OTCPK: LKYSF)  (TSX-V: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, and Optimi Health Corp., developers of a vertically integrated functional mushroom brand focused on the health and wellness sector, recently announced that they have met another early milestone in the development of an initial all natural psilocybin extract.

Optimi and Numinus, through Impact Clinical Trials Accelerator at the University of Calgary (“Impact”), have submitted a pre-clinical trial application to Health Canada for review and comment. Meanwhile, cultivation, research, formulation and continuous validation studies to produce the investigational psilocybin extract for trial continue at the Health Canada-licensed Numinus lab in British Columbia, Canada.

Field Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP) recently announced the results of a survey commissioned by Field Trip and conducted by YouGov Plc to look into the state of mental and emotional health in the US. After nearly 15 months of rolling global lockdowns due to the COVID-19 pandemic, it is to no one’s surprise that the survey results show a nation in the depths of a mental health crisis.

The survey found that over eight in ten (81%) Americans reported at least one symptom of depression and close to half of Americans reported symptoms of mild or more severe depression according to validated depression metrics. Interestingly, even though these measures indicate a nation suffering with mental health challenges, 76% of respondents self-identified their mental health as “good” or better, suggesting a disconnect with one’s self-perceived state of mind and objective measures of mental health.

Cardiol Therapeutics Inc. (OTCQX: CRTPF) (TSX: CRDL), a clinical-stage biotechnology company, is developing a proprietary subcutaneous formulation of cannabidiol to achieve higher bioavailability. This subcutaneous formulation would be a new approach to the treatment of chronic heart failure based on the anti-inflammatory activity of cannabidiol to treat inflamed heart tissue and the anti-fibrotic activity of cannabidiol to treat fibrosis (scarring) in heart muscle.

Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease. Cardiol’s subcutaneous administration of cannabidiol is designed to avoid first-pass metabolism, optimize and maintain blood levels of the drug, and target inflammation and increased fibrosis in the heart. Cardiol believes that by enhancing the bioavailability will significantly broaden the therapeutic potential of this molecule.

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