Biopharmaceutical Research Company (BRC) Announces Development and Regulatory Milestone Following Successful Type C CMC Meeting with FDA, Advancing Clinical Development of Multiple Therapeutic Candidates

• Safety and efficacy of two candidates are currently being assessed in investigator-initiated clinical trials.
• BRC is planning to commence enrollment for Phase 2 and 3 trials by mid 2026.

MONTEREY, Calif., Jan. 29, 2025 /PRNewswire/ -- Biopharmaceutical Research Company (BRC), a pharmaceutical company developing proprietary cannabinoid therapeutics, announced today that the U.S. Food and Drug Administration (FDA) reviewed the company's procedures for the Chemistry, Manufacture and Controls (CMC) of their candidates for clinical use and development. Two of BRC's therapeutics are currently being assessed in investigator-initiated Phase 1 and Phase 2 clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor Induced Arthralgia (AIIA), respectively.

"BRC has established and implemented CMC procedures for clinical use within a short time frame", said George Hodgin, CEO and founder of BRC. "Engaging with the FDA regarding our clinical and commercialization manufacturing pathways represents yet another milestone for our company and is critical towards advancing our candidates through further clinical development and ultimately commercialization."

"Over the course of less than two years, we committed ourselves to establishing our CMC procedures and having two of our candidates enter the clinic," said Lucas Zumstein, VP of Operations. "BRC now has a manufacturing facility with full cGMP capabilities for clinical use. This accomplishment is a testament to the strength of our team."

BRC's novel botanically derived cannabinoid therapeutics contain major and minor cannabinoids at defined and proprietary ratios. CMC requires the development of specific processes for manufacturing, stability and other product testing. Like any drug, BRC's candidates follow defined specifications throughout the various steps of product development towards their later-stage clinical development and eventual marketing approval.

BRC is planning to commence enrollment for Phase 2 and 3 clinical trials by mid 2026 following investigational new drug (IND) application clearance. The FDA's input on the company's manufacturing investigational product is essential for further development and will set the company on an accelerated path towards marketing approval of medicines in critical need.

About Biopharmaceutical Research Company (BRC) 
Biopharmaceutical Research Company (BRC) is a pharmaceutical company focused on developing proprietary cannabinoid therapeutics to address high unmet medical needs. BRC's therapeutics are polymodal and contain major and minor cannabinoids at defined ratios. BRC has developed a pipeline of treatments addressing pain and neurological and inflammatory conditions. BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA.

To learn more about BRC, visit https://www.biopharmaresearchco.com/ .

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the development, use, benefits and effects of Biopharmaceutical Research Company's (BRC) therapeutic product candidate and related technology, future plans for the BRC's business and growth, expected plans with respect to clinical trials, including the number of patients enrolled and timing of patient enrollment. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "design," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, BRC does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

SOURCE Biopharmaceutical Research Company