Mydecine Innovations is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics

Developing and commercializing innovative solutions for treating mental health problems and enhancing vitality Has identified four lead novel drug candidates that are unique and patentable Has exclusive access to a full cGMP certified pharmaceutical manufacturing facility What Mydecine Innovations does: Mydecine Innovations Group Inc. (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. The company also operates out of a state-of-the-art mycology lab in Denver, Colorado to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms. At the heart, Mydecine’s core philosophy is that Psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best-accredited research organizations demonstrating its remarkable clinical effectiveness. The company recognizes the responsibility associated with psychedelic-assisted therapy and has said it will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has identified four lead novel drug candidates that are unique and patentable: MYCO – 001, a pure psilocybin from natural fungal sources; MYCO – 002, an entactogenic compound that has been created with the goal of reducing harm and improving the safety profile versus MDMA; MYCO – 003, a psilocybin-based formula with reduced anxiety potential, with the aim of removing the possibility of "bad trips," even with severely ill patients; MYCO – 004, a patch delivered tryptamine compound. Properties include short duration (around two hours), transdermal, precision dosing and long-term compound stability. Mydecine president & CEO David Bartch co-founded Cannabase.io, the USA's most significant legal and sophisticated cannabis wholesale platform. In 2015, Cannabase.io was acquired by Helix TCS. The Scientific Advisory Board (SAB) that Mydecine has pulled together from its operational branches is also enviable in the field of mental health solutions. Its current members are world-renowned medical and scientific professionals drawn from within academic, research and development, military, and corporate environments. As leaders in the field of PTSD, Mental Health including clinical practice, and advocacy, each member has made significant contributions to advancing the field and are committed to furthering Mydecine’s mission. The mandate of this SAB continues to provide strategic guidance and direction for Mydecine’s clinical trials for PTSD, underpinned by pure data research, therapy, and scientific programs, advise on intellectual property; and, contribute commentary on Mydecine’s telehealth platform, Mindleap Health.  Mydecine has also successfully completed multiple acquisitions since its inception. How is it doing: Mydecine Innovations has been busy so far in 2021. On June 8, the company announced that its R&D team has made groundbreaking advances in psilocybin research with the discovery of over 40 compounds with pharmacological potential in mushrooms.  Over the past months, Mydecine’ said its R&D teams have screened over 25 mushroom species, including various varieties of p. cubensis, and has selected and analyzed over 40 unique compounds found throughout the various species. Of these compounds, a large majority appear to have never been reported before and could be vital to the critical effects of naturally-sourced mushrooms on human health and wellbeing as well as synergistic effects with pure psilocybin.  On May 19, Mydecine had provided an update on its strategic reorganization to spin out its US cannabis assets. The company said it intends to spin out its US cannabis assets and its interests in US cannabis projects into a newly incorporated subsidiary (SpinCo) and offer its holdings of common shares in SpinCo to its existing shareholders. Mydecine said it expects to receive the interim order from the Supreme Court of British Columbia on or about June 7. Then, subject to the approval of the shareholders, the reorganization (spin-out) is anticipated to close on or about the week of July 12. The purpose of the spin-out will be, among other things, to permit the company to comply with NASDAQ Listing Qualification requirements and comparable London Stock Exchange requirements regarding cannabis assets as the company continues its listing-review process with NASDAQ. Mydecine said its management believes that holding the US cannabis assets and cannabis projects in a separate public company removes an unintended obstacle to its planned NASDAQ and London Stock Exchange listings. Additionally, the company plans to leverage and monetize its US cannabis assets and cannabis projects and commercial relationships in the sector by spinning out the company’s US cannabis assets and cannabis projects into SpinCo. Under the terms of the spin-out, the company said shareholders will receive common shares of SpinCo on a pro-rata basis based on the number of common shares of the company held. The number of shares of SpinCo to be issued to each shareholder of the company under the spin-out has not yet been determined and there will be no change in shareholders’ company holdings as a result of the spin-out. The proposed spin-out will be subject to the approval of shareholders, which the company intends to seek at its next annual general and special meeting (no date set yet). The spin-out also requires the approval of the British Columbia Supreme Court. Following the completion of the spin-out, Mydecine said that SpinCo intends to make an application to list the SpinCo common shares on either the Canadian Securities Exchange or the NEO Exchange. Operationally, on May 25, Mydecine announced that it had received approval from Health Canada to “significantly expand” its cultivation capabilities at its current good manufacturing practice (cGMP) facility, at the Applied Pharmaceutical Innovation in Canada. Mydecine said that it would use the new guidance from Health Canada to expand its cultivation facilities and rapidly scale up the supply of pharmaceutical-grade psilocybin for both its internal clinical research and for its industry partners. The company said it will also allow the firm to take a “more extensive look into the diversity and undiscovered chemistry of these compounds” and test their effectiveness in treating mental health conditions like post-traumatic stress disorder (PTSD) and addiction. And on May 5, Mydecine announced a partnership with LeadGen Labs, a custom synthesis and contract research organization, to support Mydecine’s novel psychedelic drug development efforts and increase the number of novel molecules the company can synthesize concurrently. Following the announcement of the company’s four initial drug candidates, the Denver-based company said it and LeadGen Labs will work to synthesize novel psychedelic molecules. Mydecine said LeadGen Labs, which provides expertise in custom synthesis and route design, will work with the company's research and drug design team to target these novel molecular entities and enhanced formulations, including effective dosages and safety. Looking at the company’s finances, on May 18, Mydecine announced that it had ended the first quarter of 2021 with cash and equivalents of C$11.3 million, which the company said will help it advance its intellectual property portfolio, build out its clinical trial calendar, expand its European operations and develop its technology division. As well, Mydecine said its strategic partnerships are expected to expand its drug development capabilities to more efficiently and rapidly lead the next generation of psychedelic-assisted therapeutics.  The company also reported a net loss of $5.2 million for the period. In the Q1 results statement, Mydecine also noted that it submitted a formal application to list its shares on the Nasdaq Stock Exchange. And on the personnel front, on May 3, Mydecine said it had appointed William Cook as the interim CEO and Technical Director of Mindleap, the company’s first breakthrough digital technology which combines traditional telehealth, psychedelic medicine and advanced mood and behaviour tracking and analytics. The Mindleap platform offers a “powerful set of tools for managing mental healthcare,” noted the company. Cook has designed the Patriot missile system software parameters for the US Army. At Raytheon, he has led the development of Patriot software including that used in Desert Storm. Cook was the architect and led a team of over 200 engineers in developing the THAAD missile defense ‘brain’ software at Litton Industries, receiving Litton’s highest honors for technical achievement and leadership. What the boss says: In the statement with the company’s Q1 results, released on May 18, Mydecine CEO Joshua Bartch said: “Mydecine accomplished a number of key milestones in the first quarter of 2021, which collectively advanced our mission to bring one of the most robust portfolios of nature-sourced psychedelic-assisted therapeutics to the forefront of the mental health industry.” He added: “Most notably, we achieved the first-ever international export of psilocybin mushrooms and solidified our clinical and commercial supply chain in order to advance our R&D. “This supply advantage, combined with our API and LeadGens Lab partnerships, strategically advances our drug development and clinical trials, further positioning Mydecine to lead the next-generation of synthetic and naturally-derived psilocybin novel compounds.” Contact the author at jon.hopkins@proactiveinvestors.com