Mr. Evan Levine reports

PSYBIO THERAPEUTICS INITIATES COMMERCIAL BIOSYNTHETIC BASED PROCESS DEVELOPMENT FOR PSYCHO-TARGETED AND PSYCHOACTIVE COMPOUNDS

Psybio Therapeutics Corp. has initiated formal process development for commercially scalable, patent-pending manufacturing technology expected to enable good manufacturing practice (GMP) production. Psybio's manufacturing process utilizes state-of-the-art bioreactor manufacturing technology to facilitate expansion of Psybio's portfolio of compounds. This process methodology is another necessary component for the chemistry, manufacturing and controls section (CMC) for its therapeutic candidate portfolio investigational new drug (IND) applications with the United States Food and Drug Administration (FDA).

"This latest manufacturing milestone demonstrates Psybio's continued progress, maintaining our role as one of the only biotechnology companies in the psychoactive therapeutic sector developing their own compounds," stated Evan Levine, Psybio's chief executive officer. "Psybio remains committed to developing effective and scalable techniques designed to enhance our ability to produce an ever-growing number of psycho-targeted therapeutic candidates in a rapid and highly cost-efficient approach."

Psybio retains the global, exclusive and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale. Commercial purification process development furthers the ability to manufacture compounds with predictable and reproducible purity.

"The mark of successful product development is the ability to transfer technology from the bench to full-scale GMP production. Psybio has been working throughout the COVID-19 pandemic to develop commercial methodology for the manufacture of pipeline compounds using biotechnology. The initiation of GMP process development is an important step leading to clinical trial initiation," stated Michael Spigarelli, MD, PhD, MBA, Psybio's chief medical officer. "This is expected to allow us to reliably produce predictably pure drug product for clinical evaluation in order to determine its ability to potentially improve mental and neurological health."

About Psybio Therapeutics Corp.

Psybio is an intellectual-property-driven biotechnology company developing new, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently continuing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines, and combinations thereof. The company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

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