LAS VEGAS, March 15, 2022 (GLOBE NEWSWIRE) — Gb Sciences, Inc. (OTCQB: GBLX), a leading cannabis- and plant-inspired biopharmaceutical research and development company, today released a letter to shareholders from the Chairman , Scientific Director, and Director Dr Andrea Small-Howard and President and CEO John Poss, summarizing key developments in 2021 and providing strategic plans for 2022.
To our shareholders:
2021 has been a year of transformation for Gb Sciences.
In December 2021, we sold our last cannabis production facility to become a pure-play biopharmaceutical company specializing in cannabis- and plant-inspired medicines for the prescription drug market. This sale has greatly reduced our debt and allows Gb Sciences to invest all its resources in the development of our biopharmaceutical drugs. We made this strategic decision because of the immense shareholder value of our biopharmaceutical pipeline.
Additionally, moving away from cannabis production helps remove some of the barriers to listing on a national stock exchange that we would have faced as a marijuana-related business. The ability to grow the list increases opportunities for Gb Sciences to attract investment and development partners to bring our promising formulations into human clinical trials.
Our lead program in Parkinson’s disease is being prepared for a first-in-man trial through the following critical steps: a) creation of clinical prototypes by combining our proprietary formulations for Parkinson’s disease with a delivery system oral practice; b) perform a dose-response study in rodents to establish the right range of active ingredients for our first-in-human trial; c) perform the necessary ADMET tests on the clinical prototypes; and d) selecting a contract research organization (CRO) to prepare an Investigational New Drug (IND) application with the US FDA to begin our first-in-human trial.
This year, we are working with Catalent Pharma on preparing clinical prototypes of our proprietary cannabinoid-based formulations for Parkinson’s disease in Catalent Pharma’s proprietary Zydis® delivery system. Catalent Pharma’s Zydis® delivery system is an orally disintegrating tablet format that should be ideal for delivering our controlled cannabinoid ratio formulations to patients with Parkinson’s disease. Over 50% of Parkinson’s patients have difficulty swallowing, but the Zydis® format delivers the active ingredients into the mouth by dispersion without the need for water or the ability to swallow.
We chose the University of Lethbridge to begin our dose-response study in rodents, which will establish the correct dosage for our first human trial. Before filing our Investigational New Drug (IND) application, we must perform ADMET (absorption, distribution, metabolism, excretion and toxicology) testing on the clinical prototypes formulated for us by Catalent Pharma. In the Investigational New Drug (IND) application, ADMET test data will be combined with Chemistry Manufacturing and Controls (CMC) data prepared by Catalent Pharma and our Proof-of-Concept data (National Research Council Canada). In the near future, we plan to announce the selection of the contract research organization that will write the IND application and perform the first human trials.
In addition, Gb Sciences has other promising programs in late preclinical phase, including our COVID-related cytokine release formulations and our sustained-release oral nanoparticle formulations for chronic pain. The new strategy behind our COVID-related CRS program was reported in the last month The future of healthcare today. Our chronic pain formulations are being validated in animal trials at the National Research Council of Canada. Our cell-based proof-of-concept data for chronic pain nanoparticles was published this month in collaboration with the University of Seville in Spain.
In closing, we would like to thank the shareholders who have made this transition from the cannabis industry to the biopharmaceutical industry with us. Our goal is to produce maximum shareholder value while bringing innovative new treatment options to patients in need.
To learn more about Gb Sciences, visit www.gbsciences.com.
About Gb Sciences and GbS Global Biopharma
Gb Sciences, Inc. is a plant-inspired biopharmaceutical research and development company that creates patented, disease-targeted formulations of plant-inspired therapeutic blends for the prescription drug market through its Canadian subsidiary, GbS Global Biopharma, Inc. “The active ingredients in its therapeutic mixtures are synthetic counterparts identical to the original plant compounds but produced under current Good Manufacturing Practices. Gb Sciences’ intellectual property portfolio contains six issued US patents and three foreign patents issued, as well as 18 U.S. patents and 49 foreign patents pending. In its drug development pipeline, Gb Sciences has five preclinical-stage product development programs. Gb Sciences’ lead program for Parkinson’s disease is being prepared for a first clinical trial and in humans. Gb Sciences formulations for chronic pain, anxiety and depression are currently undergoing preclinical animal studies with researchers at the National Research Council of Canada. The company also recently received positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of COVID-19-related cytokine release syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Gb Sciences’ productive research and development network includes renowned universities, hospitals and contract research organizations. To learn more, visit www.gbsciences.com.
This press release may contain statements relating to future results or events, which are forward-looking statements. Words such as “expects”, “intends”, “plans”, “may”, “could”, “should”, “anticipates”, “probable”, “believes” and words of of similar significance may identify forward-looking statements. These statements are not historical facts, but rather represent the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and beyond the Company’s control. It is possible that the actual results and financial condition of the Company will differ, perhaps materially, from the expected results and financial condition indicated in these forward-looking statements. In addition, information regarding the Company and its business, including factors that could materially affect the Company’s financial and other business and results, can be found in the Company’s filings with the Securities and Exchange Commission, available at at www.sec.gov. All forward-looking statements included in this press release are made only as of the date of this press release, and we undertake no obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that occur subsequently or of which we become aware subsequently.
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