LAS VEGAS, March 16, 2022 (GLOBE NEWSWIRE) — Gb Sciences, Inc. (OTCQB:GBLX), a leading cannabis- and plant-inspired biopharmaceutical research and development company, today issued a letter to shareholders from President, Chief Science Officer, and Director Dr. Andrea Small-Howard and Chairman and CEO John Poss, summarizing key developments from 2021 and providing strategic plans for 2022. Full text of the shareholder letter follows.
A MESSAGE FROM BOTH THE PRESIDENT AND THE CHAIRMAN OF GB SCIENCES, INC.
To Our Shareholders:
2021 was a transformational year 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 greatly reduced our debt-burden and enables Gb Sciences to invest all of its resources into the development of our biopharmaceutical medicines. We made this strategic decision because of the immense shareholder value within our biopharmaceutical pipeline of products, which is estimated to be worth billions in the future if we are successful in demonstrating their safety and efficacy to the U.S. Food and Drug Administration (US FDA).
Additionally, the pivot away from cannabis production helps remove some of the barriers to up listing on a national stock exchange that we would have faced as a marijuana-touching company. The ability to up list increases the 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-human trial through the following essential steps: a) creating clinical prototypes by combining our proprietary Parkinson’s formulas with a convenient oral delivery system; b) performing a dose response study in rodents to establish the correct range of active ingredients for our first-in-human trial; c) performing necessary ADMET tests on the clinical prototypes; and d) selecting a Contract Research Organization (CRO) to prepare an Investigational New Drug (IND) application to the U.S. FDA to begin our first-in-human trial.
This year, we are working with Catalent Pharma on the preparation of 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 cannabinoid-ratio controlled formulations to Parkinson’s patients. More than 50% of Parkinson’s patients have trouble swallowing, but the Zydis® format delivers the active ingredients into the mouth by dispersion without needing water or the ability to swallow.
We have selected the University of Lethbridge to start our dose response study in rodents, which will establish the correct dosing for our first-in-human trial. Prior to filing our Investigational New Drug (IND) application, we must conduct ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicology) testing on the clinical prototypes being formulated for us by Catalent Pharma. In the Investigational New Drug (IND) application, the ADMET testing data will be combined with the 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 expect to announce the selection of the Contract Research Organization that will write the IND-application and run the first-in-human trials for our novel treatment for the motor symptoms of Parkinson’s disease.
In addition, Gb Sciences has other promising late-preclinical stage programs, including our COVID-related cytokine release formulations and our time-released oral nanoparticle formulations for chronic pain. The novel strategy behind our COVID-related CRS program was reported in last month’s Future 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 the chronic pain nanoparticles was published this month in collaboration with the University of Seville in Spain.
In closing, we would like to thank those shareholders who have made this transition from the cannabis to the biopharma industry with us. Our goal is to produce maximum shareholder value while also providing innovative new therapeutic options for patients that need them.
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 creating patented, disease-targeted formulations of plant-inspired therapeutic mixtures for the prescription drug market through its Canadian subsidiary, GbS Global Biopharma, Inc. The “plant-inspired” active ingredients in its therapeutic mixtures are synthetic homologues identical to the original plant compounds but produced under current Good Manufacturing Practices. Gb Sciences’ intellectual property portfolio contains six issued U.S. and three issued foreign patents, as well as 18 U.S. and 49 foreign patent-pending applications. In its drug development pipeline, Gb Sciences has five preclinical phase product development programs. Gb Sciences’ lead program for Parkinson’s disease is being prepared for a first-in-human clinical trial. Gb Sciences’ formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council Canada. The company also recently received positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome related to COVID-19, 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 distinguished universities, hospitals, and Contract Research Organizations. To learn more, visit www.gbsciences.com.
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