PsyBio is developing psychoactive compounds which could be a mental health game changer

Has initiated pilot scale-up of its biosynthetic formulation of psilocybin Developing a bacterial biosynthesis process for tryptamine production Well capitalized in an oversubscribed raise What PsyBio Therapeutics does: PsyBio Therapeutics Corp (CVE:PSYB) is a biotechnology company developing a portfolio of biosynthetic psychoactive compounds aimed at the treatment of mental illness and neurological disorders. The US-based company is building a portfolio of natural, non-natural, and novel formulations of psychoactive medications using genetically modified bacteria. PsyBio believes a paradigm shift for the treatment of mental health issues is “long overdue” and is focused on developing a new class of drugs. Psychoactive medications treat the illness by rewiring the brain through contemplation and a change of perception in combination with psychotherapy versus the standard treatment which just chemically treats symptoms. PsyBio has a collaboration with Miami University in Ohio where they have filed intellectual property for biosynthesized psilocybin, its intermediates, and other molecules. They have retained the global exclusive rights to a proprietary platform technology that biologically synthesizes psilocybin and other targeted next-generation psychoactive compounds that are produced naturally in Psilocybe Cubensis and other fungi. According to the company, their proprietary biosynthesis drug discovery platform is likely to spur the “rapid generation” of highly stable compounds “far cheaper, faster and greener” than any other method. The company is headed by co-founder and CEO Evan Levine, who has a strong track record as the former CEO of Adventrx Pharmaceuticals and managing partner at Brown Simpson Asset Management. The PsyBio team has broad experience in drug discovery utilizing synthetic biology. It also has extensive clinical and regulatory experience in moving drugs through human studies and regulatory protocols. How is it doing: On February 25, 2021, PsyBio debuted on the TSX Venture Exchange and its shares traded at around C$0.68 with high volume. The company successfully closed its qualifying transaction to list on the TSX by way of a three-way merger. CEO Evan Levine said the biotechnology company has received a “tremendous amount of investment interest from top tier health care funds in its oversubscribed go public round.” PsyBio closed C$14.5 million in equity financing in the fourth quarter of 2020, led by Eight Capital and Canaccord Genuity, with significant institutional participation. This is reflected in the company’s strong cash position. The company’s insider ownership is estimated at around 42%. PsyBio announced in March that it has initiated a pilot scale-up of its proprietary biosynthetic formulation of psilocybin in collaboration with Albany Molecular Research Inc. The company said it has completed Phase I of this process, including technology transfer activities, preparation of strain banks, and the adoption of analytical methods while looking forward to communicating additional progress. The company said it had moved its first production process from the laboratories of Dr J. Andrew Jones at Miami University to a commercial development facility to scale production of its proprietary biosynthetic psilocybin ahead of clinical trials. PsyBio said its proprietary platform technology allows the company to generate “high concentrations of psilocybin” without needing to incorporate the actual fungus or rely on “toxic and costly” chemical synthesis reagents. “Our methods to produce psilocybin and other tryptamines are expected to result in cheaper, faster and cleaner products than any other published methods,” Levine added. Tryptamines are a compound, of which serotonin is a derivative. Serotonin is the key hormone that stabilizes our mood, feelings of well-being, and happiness.   Dr Jones, a faculty member in the Department of Chemical, Paper, and Biomedical Engineering at Miami University, who is also chairman of PsyBio’s Scientific Advisory Board, said he was “excited” to see one of his lab’s discoveries moving towards commercialization. The technology is expected to enable the sustainable production of promising tryptamine drug candidates by fermentation of genetically engineered bacteria and is exclusively licensed to PsyBio on a worldwide, exclusive, and perpetual basis. The company is working in the lab on several psychedelically inspired compounds from different fungi and plants. PsyBio’s R&D is ongoing for natural occurring tryptamines including psilocybin in different varieties of magic mushrooms, dimethyltryptamine and its derivatives, and mescaline and combinations thereon. The company is also developing new molecule structures that do not occur in nature which may have unique therapeutics properties. PsyBio said it has already moved two of its molecules outside the research lab and they are undergoing process development and initiation of clinical batch manufacturing. “The other compounds that the company is optimizing will undergo the same pathway,” said Levine. Levine said PsyBio’s goal is to at least file an investigational new drug (IND) on psilocybin “by the end of the year and file on at least one optimized variation the following year.” The company has pending intellectual property (IP) in bacterial biosynthesis which consists of five provisional patents and 1 full patent which has been filed. Inflection points: Rapid proprietary biosynthetic formulation of psilocybin in collaboration with Albany Molecular Research Filing an IND on psilocybin by the end of the year, and filing on at least one optimized variation the following year Multiple shots on goal through optimization techniques What the boss says: In a recent interview with Proactive, PsyBio co-founder and CEO Evan Levine said: “PsyBio works in collaboration with the engineering and psychology departments at Miami University. The engineering team works on new discovery and strain and pathway optimization, the psychology department runs the experimentation through animal models.” “We believe we are one of the first researching teams designing drugs based on these metabolic interactions and we have multiple patents that we have filed based on our inventions. We have an exciting year ahead and will enjoy a tremendous amount of data to share with the community,” he added. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive