PsyBio Therapeutics Successfully Demonstrates Commercial Scale Manufacturing Feasibility

PsyBio is one of the only biotechnology companies in the psychedelic industry with the ability to manufacture therapeutics at commercial scale

OXFORD, Ohio and COCONUT CREEK, Fla., Oct. 7, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company developing new, bespoke, approvable psycho-targeted therapeutics to potentially improve mental and neurological health, today reported that it has demonstrated the ability to manufacture PsyBio-11040, one of its first promising therapeutic candidates, at commercial scale. This achievement is the result of numerous dedicated employees, consultants and contractors of PsyBio committing thousands of hours and almost a year of efforts that have taken the technology, exclusively licensed to PsyBio, from bench scale to commercial scale.

“This achievement demonstrates the formal utility of the technology to produce psycho-targeted therapeutic candidates,” stated Evan Levine, PsyBio’s Chief Executive Officer. “This is the culmination of efforts across the Company and provides a basis for our confidence moving forward with candidate development as one of the only biotechnology companies in the psychoactive therapeutic industry with the ability to manufacture therapeutics at scale.”

Scale up to full production was achieved utilizing a commercially available, stainless-steel bioreactor with integrated continuous read out probes as well as ongoing sample analysis to gather real time data on the process. Similar pilot scale processes were tested, and modifications were made as necessary to provide the information on which the larger scale processes were based. It is expected that similar scale up procedures and outcomes will be replicated across PsyBio’s therapeutic candidate strains as additional promising target candidates undergo tech transfer to commercial manufacturing. The Company expects to commence manufacturing on a commercial scale in the first quarter of 2022.

“This demonstration is very helpful as it provides the ability to manufacture a sufficient quantity of product to allow further development including producing clinical batches for preliminary stability testing and pre-clinical/clinical testing from a single production batch,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “This will allow us to move forward with the Chemistry Manufacturing and Controls (CMC) development processes as part of PsyBio’s Quality by Design (QbD) strategy to produce psycho-targeted therapeutics intended to improve mental and neurological health.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, approvable 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 ongoing 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.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability of PsyBio to commence manufacturing on a commercial scale within anticipated timeframes; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; and the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The United States Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the “TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto or Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com