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Mycotopia Therapies Announces Plan to Develop Psychedelic Sublingual Tablet to Help Treat Depression

MIAMI, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Mycotopia Therapies Inc. (OTC Pink: TPIA) (the “Company”), a biopharma company focused on research, technology, and the development of medical psychedelics, announced today it has initiated plans for a psilocybin-based pharmaceutical program by entering into an agreement to form a 50/50 joint venture (the “Joint Venture”) with Agile Pharmaceutical Solutions to develop novel oral dosage forms of psilocybin in the form of a psychedelic sublingual tablet. The two parties plan to attain a Health Canada License for psychedelics to obtain and test psychedelic raw material, for the purpose of creating the psilocybin-based, sublingual tablet to take to market.

Mycotopia Therapies and Agile Pharmaceutical Solutions plan to conduct oversight and development of the tablet in Jamaica and explore the possibility of partnering with Havn Life Sciences (CSE: HAVN) (OTC Pink: HAVLF) in Jamaica for raw materials and developing the tablet. In August Mycotopia Therapies, Inc. announced it had entered into a Psilocybin Supply Agreement with Havn Life Sciences to purchase naturally-derived psilocybin. Should the Joint Venture be granted Health Canada Psychedelics License, the terms of the agreement call for moving the operations to Canada for final testing to prove efficacy of the tablet.

Sublingual tablets are placed under the tongue. There, they dissolve rapidly beneath the tongue and enter directly into the tiny blood vessels beneath. Via these capillaries, sublingual drugs can enter the bloodstream much more quickly than oral medications. Sublingual tablets dispense the full amount of medication directly into the bloodstream without experiencing liver metabolism. As a result, physicians can prescribe smaller dosages that are guaranteed to reach their intended target. Because a sublingual dose of medicine is administered and absorbed under the tongue, it bypasses the stomach and its contents on its way to the bloodstream. As a result, sublingual drugs do not interact with foods and other medications before absorption. The dosage does not cause or experience interference by other medications and does not cause the gastrointestinal irritation of some oral medications. Individuals who have trouble swallowing or have pill aversions sometimes avoid taking medications due to the stress caused by oral medications. Sublingual versions of the same medicines can make taking prescription medications much easier, as the tablet does not need to be swallowed.

Moe Harati, Ph.D., Founder & CEO of Agile Pharmaceuticals Solutions Inc., said, "This partnership will help us to combine forces and help people live a longer healthier happier life by utilizing Agile Pharma’s intellectual property & expertise in developing innovative high-quality products and Mycotopia’s outreach and resources."

Prof. Dr. Bankole Johnson, Medical Advisor to Mycotopia Therapies‘ Board, said, “An interesting development, which may allow future further exploration of psychedelics to treat psychiatric disorders.” Bankole A. Johnson, DSc, MD, MPhil, FRCPsych is a licensed physician and board-certified psychiatrist throughout Europe and the United States who served as Alumni Professor and Chairman of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia. Dr. Johnson's primary area of research expertise is the psychopharmacology of medications for treating addictions, and he is well known in the field for his discovery that topiramate, a gamma-aminobutyric acid (GABA) facilitator and glutamate antagonist, an effective treatment for alcoholism.

In October 2018, the Food and Drug Administration granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder. Breakthrough designation allows for an accelerated pathway to approval. Currently, psilocybin is classified as a Schedule I drug in the US as it has not been approved by the FDA for any therapeutic use. According to the National Institute of Mental Health an estimated 19.4 million adults in the United States had at least one major depressive episode. This number represented 7.8% of all U.S. adults. Recent statistics from the World Health Organization show 3.8% of the world's population, approximately 280 million people, have depression. At its worst, depression can lead to suicide. Over 700 000 people die due to suicide every year. Suicide is the fourth leading cause of death in 15-29-year-olds.

Ben Kaplan, CEO of Mycotopia Therapies said, "This opportunity to develop a psychedelic sublingual tablet using the intellectual property of Agile Pharmaceutical Solutions is a tremendous opportunity for Mycotopia Therapies. The real opportunity, however, is derived from our two companies working together toward the common goal of revolutionizing how mental illness is treated. The sublingual administration presents an opportunity to possibly set a new standard for psychedelic assisted therapy.”

About Mycotopia Therapies

Mycotopia Therapies focuses on helping you heal and reclaim your life. Your journey of healing is an understanding of the causes and works to mental wellness through psychedelic enhanced psychotherapy, integrated with a professional team of mental wellness practitioners and cutting-edge technology. Psychedelic therapy is a holistic and spiritual approach providing healing and has shown successful treatment for many years. Additional information on Mycotopia Therapies can be found on the Company’s website at: https://www.mycotopiatherapies.com.

About Agile Pharmaceutical Solutions

Agile Pharmaceutical Solutions is a private biotechnology company in Canada that is focused on psychedelics, pharmaceuticals, and cannabis product innovation and Development, contract research, technology transfer and manufacturing process optimization. Dr. Moe Harati, the founder, and owner of Agile Pharmaceuticals Inc. has a PhD in Chemistry and has worked with a broad research background and training in business administration that makes him able to quickly recognize challenges and provide clear, effective solutions.

Dr. Harati is a high energy, tenacious leader that engages and inspires the team to own and execute the business plan with excellence. Over the past 20+ years, he has successfully led technical teams to product development from discovery to commercialization for various brand companies such as Pfizer, Bayer, and Proctor & Gamble. He facilitates fundamental product and process understanding and the advancement of innovative approaches to psychedelics, pharmaceuticals, and cannabis development. Dr. Harati is author and presenter of more than 200 conferences, technical summaries, publications, funding white papers, and training guides.

Dr. Harati and his team has proprietary formulations and manufacturing processes for the development of sublingual delivery of drugs for a variety of applications. Agile Pharmaceuticals can deliver a wide range of solutions for all stages of drug development including early discovery, research and development, chemistry, manufacturing, and control (CMC). http://www.agilepharmaceuticals.com

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in 20/20 Global, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.

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