BRAINS BIOCEUTICAL INITIATES CLINICAL TRIAL AGREEMENT TO TACKLE OPIOID ADDICTION

The approved investigational new drug (IND) study is for a PK study to use as a precursor in an
Opiate addiction study

VANCOUVER, BC, Feb. 9, 2022 /PRNewswire/ - Brains Bioceutical Corp ("Brains Bio" or the "Company"), a global leader in pharmaceutical EU-GMP grade Cannabidiol (CBD) Active Pharmaceutical Ingredient (API), is pleased to announce the initiation of a clinical trial, using an EU-GMP grade CBD API from their wholly-owned subsidiary BSPG Laboratories in clinical trials.

As part of this study initiation, the Icahn School of Medicine at Mount Sinai in New York, NY, is initiating the PK study with Brains Bio's oral drug formulation of CBD in a hard gelatin capsule. This preliminary data will be used as a foundation for potential future clinical trials in opioid addiction studies as well as other related disorders. It will serve as a valuable addition to Brains Bio's ongoing clinical trials, research, and development and augment the company's intellectual property portfolio.

Icahn Mount Sinai is a world-renowned leader in medical and scientific training, biomedical research and patient care. It is the medical school for the Mount Sinai Health System, which includes eight hospital campuses and has more than 7,000 faculty members and nearly 4,500 students, residents and fellows. Mount Sinai is focused on the pursuit of intellectual exchange, breakthrough research and multidisciplinary teamwork in biomedical discoveries and advances.

"We are implementing a global first within the CBD industry for this type of research with the Icahn School of Medicine at Mount Sinai, which we hope will inspire further research across the globe," said Ricky Brar, Chairman and CEO of Brains Bio. "I'm very proud of this accomplishment, wherein we have combined our strengths in producing pharmaceutical CBD API to create a unique partnership with an esteemed clinical research organization and initiate a landmark clinical trial."

"Our multidisciplinary research investigates the neurobiology underlying addiction disorders and related psychiatric illnesses," said Yasmin Hurd, PhD, Ward-Coleman Chair of Translational Neuroscience and the Director of the Addiction Institute at Mount Sinai. "We are proud to be further exploring the possibilities of CBD and its therapeutic effects. Mount Sinai is committed to the pursuit of ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients."

The team of world-renowned scientists and executives at Brains Bio continues to achieve landmark milestones with a relentless pursuit of historic firsts in the CBD industry. Brains Bio has participated in over 13 clinical trials across the globe in various therapeutic disciplines. As one of the only EU-GMP producers in the world, Brains Bio is strategically positioned to become a global leader in CBD production and research. 

"We look forward to monetizing and capitalizing on the resulting market opportunities that will result from this study," said Brar. "When it comes to the CBD industry as a whole, patients and consumers are demanding research. We are proud to be able to play a part in addressing this critical gap in the emerging industry."

Since 2014, Brains Bio's subsidiary, BSPG Laboratories located in Sandwich, Kent, United Kingdom, has been a leader in clinical-stage, natural source, cannabinoid manufacturing. Brains Bio presently has Medicines and Healthcare Products Regulatory Agency's (MHRA) approval to manufacture pharmaceutical-grade ingredients (API) for the global pharmaceutical industry.

ABOUT BRAINS BIOCEUTICAL CORP

Brains Bio is the leader in evidence-based cannabinoid and phytochemical active pharmaceutical ingredients (API) to enhance life and treatment options for consumers and patients. Headquartered in Vancouver, Canada with operations in the United Kingdom, Brains Bio is one of the only producers of natural hemp-based cannabinoid APIs in the world. Combined with the company's unparalleled expertise and institutional knowledge in biotechnology, pharmaceuticals and cannabinoid-based product development, Brains Bio is strategically positioned to be a trailblazer in healthcare innovation across the world.

CAUTIONARY STATEMENT:

This news release contains forward looking statements or forward-looking information ("forward-looking statements") within the meaning of securities laws.  Often, but not always, forward looking statements can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved.  All statements, other than statements of historical fact, in this news release are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release.  Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance are not statements of historical fact and may be forward-looking statements. Risks, uncertainties and other factors involved with forward-looking statements could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements in this news release are reasonable, there can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

SOURCE Brains Bioceutical Corp.