GB SCIENCES, INC. The following discussion and analysis contains "forward-looking statements," as defined inthe United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "could", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts" or "continue" , which list is not meant to be all-inclusive and other such negative terms and comparable technology. These forward-looking statements, include, without limitation, statements about our market opportunity, our strategies, competition, expected activities and expenditures as we pursue our business plan, and the adequacy of our available cash resources. Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Actual results may differ materially from the predictions discussed in these forward-looking statements. The economic environment within which we operate could materially affect our actual results. Additional factors that could materially affect these forward-looking statements and/or predictions include among other things: (1)product demand, market and customer acceptance ofGB Sciences products, equipment and other goods, (ii) ability to obtain financing to expand its operations, (iii) ability to attract qualified personnel, (iv)competition pricing and development difficulties, (v) general industry and market conditions and growth rates, unexpected natural disasters, and other factors, which we have little or no control: and other factors discussed in the Company's filings with theSecurities and Exchange Commission ("SEC"). The Company does not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this report. The following discussion highlights the Company's results of operations and the principal factors that have affected our financial condition, as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis is based on the Company's unaudited financial statements contained in this Quarterly Report, which we have prepared in accordance withUnited States generally accepted accounting principles. You should read this discussion and analysis together with such financial statements and the related notes thereto. OverviewGB Sciences, Inc. ("the Company", "GB Sciences", "we", "us", or "our") is a plant-based research and biopharmaceutical drug development company whose goal is to create patented formulations of plant-inspired, minimum essential mixtures for the prescription drug market that target a variety of medical conditions. The Company is engaged in the research and development of plant-based medicines and plans to produce plant-inspired, minimum essential mixtures based on its portfolio of intellectual property. Through its wholly owned Canadian subsidiary,GBS Global Biopharma, Inc. ("GBSGB"), the Company is engaged in the research and development of plant-based medicines, primarily cannabinoid medicines, with virtual operations inNorth America andEurope . GBSGB's assets include a portfolio of intellectual property containing both proprietary plant-inspired formulations and our AI-enabled drug discovery platform, as well as critical research contracts and key supplier arrangements. GBSGB's intellectual property covers a range of medical conditions, and five product development programs are in the preclinical animal stage of development including Parkinson's disease (PD), chronic pain, COVID-related cytokine release syndrome, depression/anxiety, and cardiovascular therapeutic programs. GBSGB is assertively preparing its PD therapeutics for a first-in-man trial. Depending on the results of on-going preclinical studies, either chronic pain or the COVID-related cytokine release syndrome therapies will be headed for the clinic after PD. GBSGB runs a lean drug development program and takes effort to minimize expenses, including personnel, overhead, and fixed capital expenses through strategic partnerships with Universities and Contract Research Organizations ("CROs"). GBSGB's intellectual property portfolio includes five USPTO issued patents, fourteen USPTO nonprovisional patent applications pending in the US, and seven provisional patent applications in the US. In addition to the USPTO patents and patent applications, the company has filed 41 patent applications internationally to protect its proprietary technology and formulations. In October of 2021, we filed the nonprovisional USPTO patent application to further protect aspects of our proprietary drug discovery engine, "Phytomedical Analytics for Research Optimization at Scale," or PhAROS™. We were incorporated in theState of Delaware onApril 4, 2001 , under the name "Flagstick Venture, Inc. " OnMarch 28, 2008 , stockholders owning a majority of our outstanding common stock approved changing our then name "Signature Exploration and Production Corp. " as our business model had changed. OnApril 4, 2014 , we changed our name fromSignature Exploration and Production Corporation toGrowblox Sciences, Inc. EffectiveDecember 12, 2016 , the Company amended its Certificate of Corporation pursuant to shareholder approval, and the Company's name was changed fromGrowblox Sciences, Inc. toGB Sciences, Inc.
Effective
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Table of Contents Plan of Operation
Drug Discovery and Development of Novel Cannabis-Based Therapies
Through its wholly owned Canadian subsidiary,GBS Global Biopharma, Inc. ("GBSGB"), the Company has conducted ground-breaking research embracing the rational design of plant-based medicines led by Dr.Andrea Small-Howard , the Company's Chief Science Officer and Director, and Dr.Helen Turner , Vice President of Innovation and Dean of theNatural Sciences and Mathematics Department atChaminade University . Small-Howard and Turner posited that minimum essential mixtures of plant-based ingredients would provide more targeted and effective treatments for specific disease conditions than either single ingredient or whole plant formulations. They developed a rapid screening and assaying system which tested thousands of combinations of cannabinoids and terpenes in vitro against cell-based models of disease. This process identified precise mixtures of cannabinoids and terpenes, many of which contained no THC, to treat categories of disease conditions, including neurological disorders, inflammation, heart disease, metabolic syndrome, chronic and neuropathic pain. GBSGB's drug discovery engine involves both high throughput screening of cell models of disease and a data analytics/machine learning tool to expedite drug discovery. Initially, GBSGB explored the potential medical uses of specific mixtures derived from cannabis-based raw materials, but these tools are also effective for investigating the medical applications of complex therapeutic mixtures from any plant-derived starting material. In 2014, GBSGB developed its first rapid screening and assaying system which tested thousands of combinations of cannabinoids and terpenes against cell-based models of diseases. This process has been refined over the years and now has identified precise mixtures of cannabinoids and terpenes, many of which contained no THC, to treat categories of disease conditions, including neurological disorders, inflammation, heart disease, metabolic syndrome, chronic and neuropathic pain. GBSGB has filed for patent protection on these plant-inspired, minimum essential mixtures, and they are testing them in disease-specific animal models in preparation for human trials. GBSGB's drug discovery process combines: 1) HTS: high throughput screening of tens of thousands of combinations of compounds derived from plants in well-established cellular models of diseases, and 2) PhAROS™: Phytomedical Analytics for Research Optimization at Scale for the prediction of minimum essential mixtures from plant-based materials. This combined approach to drug discovery increases research efficiency and accuracy reducing the time from ideation to patenting from 7 years to 1.5 years. Screening of plant-based mixtures for drug discovery involves the testing of specific combinations of plant chemicals from many naturally occurring plants and the use of live models for these diseases that have been well established by other researchers. First, the Company finds plant materials that show some therapeutic activity, and then refines these natural mixtures to optimize their effectiveness in cellular assays by removing compounds that do not act synergistically with the others in the mixtures. The goal is to identify minimum essential mixtures (MEM) that retain the efficacy of the whole plant extracts, but with the manufacturing and quality control advantages of single ingredient pharmaceutical products. The Company also use its PhAROS™ Platform to prioritize and eliminate some potential combinations, which reduces the time in the discovery period. PhAROS™ can also be used to identify and predict the efficacy of plant-derived, minimum essential mixtures for specific diseases in silico, which are then tested in cell and animal models. In October of 2021, GBSGB began its first preclinical animal trial of non-cannabis-based formulations that were discovered and pre-validated using our PhAROS™ drug discovery platform.The National Research Council of Canada ("NRC") will test GBSGB' proprietary, psychotropic plant-based formulas for the treatment of depression and anxiety. For these novel psychotropic drug candidates, the GBSGB research team used the PhAROS™ platform to identify new ingredients to improve upon an initial formulation for anxiety based on traditional medicine. The original plant mixture was derived from the kava plant, but some elements of kava are thought to cause liver toxicity. PhAROS™ identified ingredients from the Piper plant family as a substitute for the functionality of the ingredients in question without the potentially adverse safety profiles of those original ingredients. The Piper plant family includes pepper plants that are used worldwide in traditional medicines. GBSGB's new psychotropic formulations are currently in preclinical trials at the Zebrafish Toxicology,Genomics and Neurobiology Lab at the NRC, led by Dr.Lee Ellis , Research Officer and Team Lead. The ongoing work between the NRC and GBSGB has produced strong and applicable data for the evaluation of its therapies, and this trial could provide novel treatment options for patients with depression and anxiety. TheU.S. Patent and Trademark Office allows complex mixtures to be claimed as Active Pharmaceutical Ingredients ("APIs"). GBSGB has five issued patents, plus a series of pending patents containing plant-derived complex mixtures and minimum essential mixtures that act as therapeutic agents for specific disease categories, as described below. GBSGB's pending patents are protected whether the individual compounds are derived from the cannabis plant, another plant, synthetically produced, or derived from a combination of sources for the individual chemical compounds in these mixtures. 31
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Table of Contents Drug Development ProgressGBS Global Biopharma, Inc. has made significant strides in the past year with respect to both its drug discovery research and product development programs. GBSGB now has five preclinical phase product development programs and is aggressively preparing its lead formulations for the treatment of Parkinson's disease for a first-in-man clinical trial. GBSGB's chronic pain, anxiety, and depression formulations are currently in preclinical animal studies with Dr.Lee Ellis of theNational Research Council ("NRC")Canada inHalifax, Nova Scotia . Recently, we received positive preclinical, proof-of-concept data supporting our minimum essential mixtures for the treatment of Cytokine Release Syndrome in COVID-19 (COVID-CRS) and other severe hyperinflammatory conditions. GBSGB's lead COVID-CRS candidates will be optimized based on late-stage preclinical studies with Dr.Norbert Kaminski atMichigan State University . Our growing intellectual property portfolio was augmented with additional patent-protections for our PhAROS™ drug discovery platform, new PhAROS™ discovered, non-cannabis formulations, and improved formulations for our PD therapeutics. For the Company's lead program in PD therapeutics, GBSGB has improved upon the efficacy of their original formulations and filed a new patent application family to protect GBSGB's defined cannabinoid ratio-minimum essential mixtures (DCR-MEMs) for the treatment of Parkinsonian motor symptoms. GBSGB had announced previously that it has obtained the statistically significant reduction of Parkinson's-disease like symptoms using proprietary cannabinoid-containing MEMs in an animal model of Parkinson's disease ("PD"). Three of GBSGB's PD formulations significantly reduced the PD-like motor symptoms. In addition, the toxicity studies for these original PD formulas came back without any significant negative findings. These initial efficacious PD formulations were equimolar minimum essential mixtures (E-MEMs), wherein, each contained three cannabinoids combined at an equimolar ratio (1:1:1). In the past year 2020-2021, GBSGB has screened an additional sixty-three variations of the original three equimolar MEMs and identified a total of twenty-two DCR-MEMs with optimized ratios of cannabinoids that produced a statistically significant reduction in OHDA induced motor symptoms. Five of these twenty-two efficacious MEMs outperformed the original equimolar cannabinoid MEMs. A new patent application has been filed to protect these DCR-MEMs. These important preclinical results will be included in GBS' Investigational New Drug ("IND") application with theUS FDA to enter human clinical trials as soon as possible. New therapies to address Parkinson's disease symptoms are needed to help those afflicted with this debilitating disease. The combined direct and indirect costs associated with Parkinson's disease are estimated at$52 billion in theU.S. alone. For GBSGB's Parkinson's disease therapies, the initial clinical prototypes of GBSGB's Defined Cannabinoid Ratio (DCR)-MEM are being formulated by Catalent Pharma using Catalent's Zydis® Orally Disintegrating Tablet ("ODT") technology. This ODT format was selected for the PD formulas because it dissolves on the tongues of patients without the need to swallow for ease of use in patients with PD, who often have difficulties with swallowing. Previously, GBSGB has completed two proof-of-concept studies for its MEM. Now, GBSGB is performing a Feasibility Study that will produce and validate the clinical prototypes for its DCR-MEM. GBSGB selected Catalent as its development partner for the PD therapies due to Catalent's prior experience in working onUS FDA -approved, cannabinoid-containing drugs, their Schedule I drug manufacturing facilities, their familiarity withUS FDA and international regulatory and manufacturing requirements, their expertise in tackling formulation challenges, and their ability to achieve the stability and dosing necessary for these novel therapeutic mixtures. In addition to its Zydis® technology, Catalent has early drug development services and additional oral drug delivery solutions available for the efficient delivery of GBSGB's proprietary APIs. For its lead chronic pain program, GBSGB is testing its MEM for chronic pain both as encapsulated, time-released nanoparticles, as well as in non-encapsulated forms of these therapeutic mixtures in an animal model at the NRC inHalifax, Nova Scotia . In preparation for human clinical trials, our standard MEM and the time-released MEM are currently being compared in an animal model that demonstrates their potential effectiveness at treating chronic pain. The early results from this preclinical research project look very promising. However, the COVID pandemic adversely affected the progress on this study, but we are happy to report that we are back on track to continue with the testing of these promising chronic pain formulations. In late summer of 2021, GBSGB received positive proof-of-concept data from a human immune cell model supporting the efficacy of their proprietary MEM designed for the suppression of COVID-related, cytokine release syndromes (CRS) while preserving key anti-viral immune responses. Based on this new positive proof-of-concept data, GBSGB converted their provisional patent application entitled, "CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF CYTOKINE RELEASE SYNDROME WHILE PRESERVING KEY ANTI-VIRAL IMMUNE REACTIONS" to a nonprovisional patent application onAugust 18, 2021 . The best performing MEM will be further developed in preparation for clinical studies to evaluate their anti-inflammatory potential in the treatment of severely ill COVID-19 patients contending with Cytokine Release Syndrome (CRS) and associated hyperinflammatory conditions, such as macrophage activation syndrome (MAS) and acute respiratory distress syndrome (ARDS). CRS, MAS, and ARDS are the leading causes of deaths in COVID-19 patients. GBSGB's proof-of-concept study was performed atMichigan State University using a state-of-the-science human immune model. In GBSGB's proof-of-concept study, immune cells from human donors were co-cultured together in one of four treatment groups: untreated (no inflammatory stimulus), inflammatory stimulus, control (inflammatory stimulus + vehicle from cannabinoid mixtures), or pre-treatment with the cannabinoid mixture + inflammatory stimulus. Then a panel of cytokines and inflammatory markers was measured from each of these treatment groups from different immune cell types within the co-cultured cells at four time points to determine whether GBSGB's MEMs were able to alter the levels of pro-inflammatory cytokines or other inflammatory agents. GBSGB's COVID-CRS formulations showed potential for the selective inhibition of pro-inflammatory processes in response to viral- and bacterial-triggered hyperinflammation in a human immune cell model. These positive proof-of-concept results support the potential for some of these mixtures to accomplish our therapeutic goals, but, ultimately, clinical trial results will determine whether they are efficacious. GBSGB's plant-based drug discovery platform is advancing biopharmaceutical research at a time when thousands are dying from COVID-19. The next step is to further develop our plant-inspired drugs and eventually bring them to human trials so that the use of well-defined cannabinoid mixtures in clinical practice can become a reality. 32
-------------------------------------------------------------------------------- As mentioned above, the Company recently announced that the NRC Canada will test GBSGB's proprietary, psychotropic plant-based formulas for the treatment of depression and anxiety in preclinical animal studies. GBSGB has leveraged its patent-pending PhAROS™ (Phytomedical Analytics for Research Optimization at Scale) platform to identify these combinations of plant compounds for novel drug candidates to treat depression and anxiety. These are the company's first non-cannabis formulations to enter preclinical studies. For these novel psychotropic drug candidates, the GBSGB's research team used the PhAROS™ platform to identify new ingredients to improve upon an initial formulation for anxiety based on traditional medicine. The original plant mixture was derived from the kava plant, but some elements of kava are thought to cause liver toxicity. PhAROS™ identified ingredients from the Piper plant family as a substitute for the functionality of the ingredients in question without the potentially adverse safety profiles of those original ingredients. The Piper plant family includes pepper plants that are used worldwide in traditional medicines. The Global Anxiety Disorder and Depression Treatment Market size is forecast to reachUSD 19.81 Billion by 2028 according to Reports & Data. Favorable Research Updates from our university collaborators reveal the promise in our discovery programs including: 1) Multiple MEM discovery projects using and advancing GBSGB's proprietary PhAROS™ drug discovery platform in conjunction withChaminade University , 2)GBSGB's Cannabis Metabolomics Project with bothChaminade University ofHonolulu , Hawai'i and theUniversity of Athens, Greece , and 3) GBSGB's Applied Time-Released Nanoparticles for Delivery of Cannabis-based Ingredients with theUniversity of Seville, Spain and theUniversity of Cardiz ,Spain . This year, our growing intellectual property portfolio was augmented with additional patent-protections for our PhAROS™ drug discovery platform that were filed in July of 2021 and in October of 2021. GBSGB also filed for protection of new PhAROS™ discovered, non-cannabis formulations in July of 2021. In September of 2021, GBSGB filed a patent application for the Company's improved DCR-MEM formulations for our PD therapeutic program. These new patent applications expanded upon the solid foundation of intellectual property developed over the past six years. In 2020, the three patents which protect formulations for the Company's lead therapeutic programs were issued by the USPTO. The issuance ofU.S. Patent No. 10,653,640 entitled "Cannabinoid-Containing Complex Mixtures for the Treatment of Neurodegenerative Diseases" onMay 19, 2020 protects methods of using GBSGB's proprietary cannabinoid-containing complex mixtures (CCCM™) for treating Parkinson's Disease. This was an important milestone in the development of these vitally-important therapies and validates GBSGB's drug discovery platform. In the US alone, the combined direct and indirect costs associated with Parkinson's disease are estimated at$52 billion , and new therapies to address Parkinson's disease symptoms are greatly needed. This was also the first time that a US patent has been awarded for a cannabis-based complex mixture defined using this type of drug discovery method. The first US patent for PD therapies validated our drug discovery platform and strengthened our intellectual property portfolio of unique CCCM's™, each targeting one of up to 60 specific clinical applications. The issuance of GBSGB's second and third US patents for active pharmaceutical ingredients that are complex mixtures identified by our biotech platform further confirmed that GBSGB's pharmaceutical compositions can be patent-protected for use as biopharmaceutical and nutraceutical products. The US Patent entitled "Myrcene-Containing Complex Mixtures Targeting TRPV1" protects methods of using GBSGB's proprietary MEMs for the treatment of pain disorders related to arthritis, shingles, irritable bowel syndrome, sickle cell disease, and endometriosis. In the US alone, chronic pain represents an estimated health burden of between$560 and$650 billion dollars , and an estimated 20.4% ofU.S. adults suffer from chronic pain that significantly decreases their quality of life. Despite the widespread rates of addiction and death, opioids remain the standard of care treatment for most people with chronic pain. The Company believes that it is important to create safer, less addictive alternatives to opioids for the treatment of chronic pain disorders, like GBSGB's myrcene-containing MEMs. The US Patent entitled "Cannabinoid-Containing Complex Mixtures for the Treatment of Mast-Cell-Associated or Basophil-Mediated Inflammatory Disorders" protects methods of using GBSGB's proprietary MEMs for treating Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. Receiving this patent for the treatment of MCAS using GBSGB's MEMs is an important milestone in the development of this urgently needed medicine. There is no single recommended treatment for MCAS patients. Instead, they attempt to manage MCAS symptoms primarily by avoiding 'triggers' and using rescue medicines for their severe hyperinflammatory attacks. Therefore, MCAS patients need new therapeutic options to control their mast cell related symptoms, and our MEMs were designed to simultaneously control multiple inflammatory pathways within mast cells as a comprehensive treatment option. The Company is strategically targeting MCAS for two additional reasons. By focusing on a rare disease with no known cure, our company can apply for theU.S. Food and Drug Administration's expedited approval process, which allows clinically successful treatments to get to market both quicker and more cost effectively. Gaining approval from theUS FDA for the entire anti-inflammatory market would be extremely time consuming and cost prohibitive. Demonstrating that our MEMs are safe for the treatment of MCAS would favorably position our Company for clinical testing of these MEMs as potential treatments for other related inflammatory disorders, such as inflammatory bowel disease, thereby widening the target market and drastically shortening the development cycle and costs. 33
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Table of Contents
Intellectual Property Portfolio
GBSGB retained Fenwick & West, aSilicon Valley based law firm focusing on life sciences and high technology companies with a nationally top-ranked intellectual property practice, to develop strategies for the protection of the Company's intellectual property. The status of the intellectual property portfolio is as follows. Unless otherwise indicated, all patents listed below are assigned to the Company's wholly owned subsidiary,GBS Global Biopharma, Inc. Issued Patents
Title: CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF NEURODEGENERATIVE DISEASES
U.S. Patent Number: 10,653,640 Expiration date: October 23, 2038 Issued: May 19, 2020 Inventors: Andrea Small-Howard et al.
Title: MYRCENE-CONTAINING COMPLEX MIXTURES TARGETING TRPV1
U.S. Patent
Number: 10,709,670 Expiration date: May 22, 2038
Issued: July 14,
2020 Inventors: Andrea Small-Howard, et al.
GBSGB's MCCMs are protected in the
Title: CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF MAST CELL-ASSOCIATED OR BASOPHIL-MEDIATED INFLAMMATORY DISORDERS
U.S. Patent Number: 10,857,107 Expiration date: January 31, 2038 Issued: December 8, 2020 Inventors: Andrea Small-Howard et al.
Title: METHODS AND COMPOSITIONS FOR PREVENTION AND TREATMENT OF CARDIAC HYPERTROPHY
Inventor: Alexander
Stokes Assignee: University of Hawai'i
U.S. Patent
Number: 9,084,786 Issued: July 21, 2015
U.S. Patent
Number: 10,137,123 Issued: November 27, 2018
E.U. Patent
Number: 2,635,281 Issued: March 14, 2018
Hong Kong
Patent Number: 14102182.8 Issued: March 14, 2018
GBSGB has sublicensed from Makai Biotechnology, LLC these two issued USPTO patents and two issued
international patents for the prevention and treatment of heart failure due to cardiac
hypertrophy through therapeutic regulation of TRPV1.
Title: METHOD FOR PRODUCING A PHARMACEUTICAL COMPOSITION OF POLYMERIC NANOPARTICLES FOR
TREATING NEUROPATHIC PAIN CAUSED BY PERIPHERAL NERVE COMPRESSION
Spain Patent ES2582287 Inventors: Lucia Martin Banderas, Mercedes
Number: Fernandez Arevalo, Esther Berrocoso
Dominguez, Juan Antonio Mico Segura
Issued: September Assignees: Universidad de
29, 2017 Cadiz, Centro de Investigacion
Biomedica En Red
Exclusive worldwide license held by GBS Global Biopharma, Inc. Claims benefit of Spanish
Patent Application No. P201500129 (Pub. No. ES 2582287). GBSGB holds the exclusive rights to
commercialize these cannabinoid-containing, time-released, oral nanoparticles for the
treatment of neuropathic pain.
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Table of Contents
In addition to the issued patents listed above, GBSGB's intellectual property
portfolio includes a total of 14 USPTO and 41 international patents pending:
Other
International
Application Applications
Title Jurisdiction Number Filed Continuation of
CANNABINOID-CONTAINING COMPLEX US USPTO 16/844,713 AU, CA, CN, 15/729,565
MIXTURES FOR THE TREATMENT OF PCT/US2017/055989 EP, HK, IL, JP
NEURODEGENERATIVE DISEASES
MYRCENE-CONTAINING COMPLEX US USPTO 16/878,295 AU, CA, CN, 15/986,316
MIXTURES TARGETING TRPV1 PCT/US2018/033956 EP, HK, IL, JP
CANNABINOID-CONTAINING COMPLEX US USPTO 17/065,400 AU, CA, CN, 15/885,620
MIXTURES FOR THE TREATMENT OF PCT/US2018/016296 EP, HK, IL, JP
MAST CELL-ASSOCIATED OR
BASOPHIL-MEDIATED INFLAMMATORY
DISORDERS
TRPV1 ACTIVATION-MODULATING US USPTO 16/420,004 AU, CA, CN,
COMPLEX MIXTURES OF CANNABINOIDS PCT/US2019/033618 EP, HK, IL, JP AND/OR TERPENES THERAPEUTIC NANOPARTICLES US USPTO 16/686,069 ENCAPSULATING TERPENOIDS AND/OR PCT/ES2019/070765
CANNABINOIDS
TREATMENT OF PAIN USING US USPTO 16/914,205
ALLOSTERIC MODULATOR OF TRPV1 PCT/US2020/039989
CANNABINOID-CONTAINING COMPLEX US USPTO 63/067,269
MIXTURES FOR THE TREATMENT OF (provisional)
CHRONIC INFLAMMATORY DISORDERS
CANNABINOID-CONTAINING COMPLEX US USPTO 17/406,035
MIXTURES FOR THE TREATMENT OF PCT/US2021/046584
CYTOKINE RELEASE SYNDROME WHILE
PRESERVING KEY ANTI-VIRAL IMMUNE
REACTIONS
IN SILICO META-PHARMACOPEIA US USPTO 17/501,498
ASSEMBLY FROM NON-WESTERN MEDICAL PCT/US2021/055056
SYSTEMS USING ADVANCED DATA
ANALYTIC TECHNIQUES TO IDENTIFY
AND DESIGN PHYTOTHERAPEUTIC
STRATEGIES
METHODS AND COMPOSITIONS FOR EU EPO 3,348,267 IN, CN
PREVENTION AND TREATMENT OF
CARDIAC HYPERTROPHY
METHOD FOR PRODUCING A WIPO/PCT WIPO 2016/128591 EU, CA
PHARMACEUTICAL COMPOSITION OF PCT/ES2016/000016
POLYMERIC NANOPARTICLES FOR
TREATING NEUROPATHIC PAIN CAUSED
BY PERIPHERAL NERVE COMPRESSION
CANNABINOID-CONTAINING US USPTO 63/249,482
FORMULATIONS FOR PARKINSONIAN (provisional)
MOVEMENT DISORDERS
METHODS AND COMPOSITIONS FOR THE US USPTO 63/221,334
IDENTIFICATION OF NOVEL (provisional)
THERAPEUTIC APPROACHES TO
MIGRAINE USING THE PHAROS IN
SILICO DRUG DISCOVERY PLATFORM
METHOD AND COMPOSITIONS FOR THE US USPTO 63/221,358
PHYTOMEDICAL COMPONENT SUPPLY (provisional)
CHAIN DECISION SUPPORT USING THE
PHAROS IN SILICO DRUG DISCOVERY
PLATFORM
METHODS AND COMPOSITIONS FOR US USPTO 63/221,364
NOVEL PAIN THERAPIES INCLUDING (provisional)
OPIOID-ALTERNATIVE STRATEGIES
IDENTIFIED USING THE PHAROS IN
SILICO DRUG DISCOVERY PLATFORM
METHODS AND COMPOSITIONS FOR US USPTO 63/221,366
NOVEL PAIN THERAPIES TARGETED TO (provisional)
SPECIFIC PAIN SUBTYPES IDENTIFIED
USING THE PHAROS IN SILICO DRUG
DISCOVERY PLATFORM
METHODS AND COMPOSITIONS US USPTO 63/221,367
DEVELOPMENT OF NOVEL THERAPEUTICS (provisional)
BASED ON PIPER SPECIE-CONTAINING
PHYTOMEDICINES FOR ANXIETY AND
ASSOCIATED DISORDERS USING THE
PHAROS IN SILICO DRUG DISCOVERY
PLATFORM
METHODS AND COMPOSITIONS FOR US USPTO 63/221,371
DECONVOLUTION OF COMPLEX (provisional)
PHYTOMEDICAL FORMULAE FOR CANCER
TO IDENTIFY TARGETED STRATEGIES
FOR CANCER PAIN AND CYTOTOXIC
THERAPEUTIC CANDIDATES USING THE
PHAROS IN SILICO DRUG DISCOVERY
PLATFORM
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Table of Contents
Partnering Strategy
GBSGB runs a lean drug development program and minimizes expenses, including
personnel, overhead, and fixed capital expenses (such as lab and diagnostic
equipment), through strategic partnerships with Universities and Contract
Research Organizations ("CROs"). Through these research and development
agreements, GBSGB has created a virtual pipeline for the further development of
novel medicines extracted from the cannabis plant. The partners bring both
expertise and infrastructure at a reasonable cost to the life sciences program.
In most instances, GBSGB has also negotiated with these partners to keep 100% of
the ownership of the IP within GBSGB for original patent filings.
GBSGB currently has on-going research agreements with the following institutions covering the indicated areas of research:
Chaminade University : Broad-based research program to support the drug discovery platform that has yielded many of GBSGB's original patents to date in the areas of neurodegenerative diseases, heart disease, inflammatory diseases, neuropathic and chronic pain. They have also performed the bioassay portion of the Cannabis Metabolomics study performed with theUniversity of Athens, Greece and GBSGB. Our collaborations with Chaminade also led to the development of our PhAROS™ drug discovery platform.University of Athens : Broad-based metabolomics analysis of over 100 cannabis genotypes including both hemp and THC-producing cannabis varieties, in combination with GBSGB's bioassay data linking genotypes and potential disease-remediations. This project has the potential to define active ingredients from plant-derived mixtures beyond the standard cannabinoids and terpenoids. The discovery potential is huge, and novel agents have recently been discovered.Michigan State University : Preclinical work using a cutting-edge, multi-cellular model of the human immune system and a multi-cell model of the brain to validate our MEMs for use in the treatment of COVID-19-related cytokine release syndromes (COVID-CRS). MSU has performed experiments using their novel model of the human-immune system that have allowed GBSGB to prepare cannabis-based formulas for the potential treatment of virally-induced hyperinflammation/cytokine storm syndrome that has led to the majority of COVID-19 deaths. Positive proof-of-concept results have guided the development of these selectively anti-inflammatory MEM.The University of Seville : Bringing their novel expertise to the development and functional testing of time-released and disease-targeted nanoparticles of cannabis-based minimum essential mixtures for oral administration. These specialized nanoparticles are being used for the precise and time-released delivery of several of our therapies, including GBSGB's chronic pain MEMs used in the preclinical animal testing performed at the NRC Canada.The University of Seville has completed functional testing on nanoparticles containing myrcene, nerolidol, and beta-caryophyllene for our chronic pain MEMs. In cell-based assays, the effectiveness and kinetics of the nanoparticle-forms of these terpenes were compared with the "naked" terpenes both individually and in mixtures. In all cases, the effectiveness of the nanoparticles were superior to the naked terpenes, however, the mixtures were dramatically more effective than the individuals. Our partners at theUniversity of Seville are adding new cannabis-based ingredients into the oral, time-released nanoparticle format for the completion of our maximally effective MEMs for chronic pain. The results fromSeville are very promising, and these nanoparticles have entered the animal testing phase at the NRC inHalifax .The National Research Center (NRC) ofCanada ,Halifax, Nova Scotia : Four animal-phase studies are being performed by Dr.Lee Ellis' group at the NRC. 1) Parkinson's Disease: In Q1 of 2020, an animal safety and efficacy study was completed for GBSGB's equimolar MEMs for the treatment of the motor symptoms of Parkinson's disease, and the NRC has demonstrated that the company's PD formulations were able to reduce behavioral changes associated with the loss of dopamine-producing neurons, which underlies the pathology of Parkinson's disease in the animal model. Based on achieving the statistically significant reduction in Parkinson's disease symptomology in these equimolar MEMs, GBSGB completed a final phase of testing in August of 2021, which identified five defined cannabinoid ratio (DCR)-MEMs that were more effective than the root equimolar MEM. 2) Chronic Pain: In Q1 of 2019, GBSGB started a safety and efficacy study in animals for GBSGB's Chronic Pain (CP) formulas. The midterm results for these preclinical pain studies were promising, but the study was significantly delayed by the COVID pandemic. 3 & 4) Depression and Anxiety: Minimum essential mixtures of plant-based ingredients from kava and the related Piper plant family are being evaluated now.The University of Cadiz : Testing the safety and efficacy of the above-mentioned time-released nanoparticles in rodent models of chronic pain. Proof of concept complete for one formulation.
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Table of Contents
Path to Market: Drug Development Stages and Proposed Clinical Trials
GBSGB has plant-based therapeutic products in the following stages of drug development: Discovery, Pre-Clinical, and entering the Clinical Phase. It has also licensed therapeutic products that the Company intends to develop through partners, labeled Partner Programs. The completion of discovery, preclinical studies, clinical trials, and the required regulatory submissions required for obtainingUS FDA pre-market approvals for pharmaceutical products (and equivalent approvals from other corresponding agencies worldwide) is traditionally a long and expensive process. However, GBSGB asserts that its proprietary, PhAROS™, AI-enabled, drug discovery engine; plant-inspired formulations; lean development program; novel regulatory strategy; experienced development partners; and aggressive licensing of these products at early clinical stages can mitigate some of the risks. The Company uses a combination of in silico discovery methods and automated screening of cellular and animal models of disease to decrease the time in Discovery prior to filing novel patent applications for disease-specific therapeutics. GBSGB's original patent applications cover new chemical entities ("NCE") based on discovery and validation of minimum essential mixtures derived from complex, plant-based therapeutics. GBSGB plans to use an Exploratory IND/Phase 0 Program that gets the Company to First-in-Man sooner than traditional programs, which reduces translational risks, and includes preliminary efficacy measures for responsible development decisions. In contrast, a traditional phased-development path would not provide any efficacy measures until Phase II. After the completion of our Phase 0 study for PD, which compares the efficacies of multiple related cannabinoid-based formulations, the Company plans to advance the lead PD drug candidate using an adaptive trial design that is more efficient than the traditional phased-development pathway. GBSGB has entered into research contracts, partnerships, and/or joint ventures with several respected, independent contract research organizations, medical schools, universities, and with other scientific consultants to increase developmental efficiencies. If and when one or more of GBSGB's drugs, therapies or treatments are approved by the FDA, GBSGB will seek to market them under licensing arrangements with major biotechnology or pharmaceutical companies. There can be no assurance that we will ever be able to enter into any joint ventures or other arrangements with third parties to finance our drug development program or that if we are able to do so, that any of our projected therapies will ever be approved by the FDA. Even if we obtainUS FDA approval to market one of our therapies, there can be no assurance that it could be successfully marketed or would not be superseded by another plant-based therapy produced by one or more of our competitors. It also may be anticipated that even if we enter into a joint venture development with a financially stable pharmaceutical or institutional partner, we will still be required to raise significant additional capital in the future to achieve the strategic goals of GBSGB. There can be no assurance that we will be able to obtain such additional capital on reasonable terms, if at all. If GBSGB fails to achieve its goal of producing one or more plant-inspired pharmaceuticals or therapies, it would have a material adverse effect on our future financial condition and business prospects. 37
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Table of Contents Other Operations In addition to our key biopharmaceutical research and development activities described in detail above, the Company has operated in the medical and adult-use cannabis markets under State-issued cultivation and production licenses. Our wholly owned subsidiaryGB Sciences Nevada, LLC ("GBSN") leases a warehouse facility at3550 W. Teco Avenue ,Las Vegas Nevada (the "Teco Facility") and operates a cannabis cultivation facility underNevada licenses for the medical and adult-use markets. Our wholly owned subsidiaryGB Sciences Las Vegas, LLC ("GBLV") holdsNevada certificates for medical and adult-use cannabis production and produces extracts and concentrates for the wholesale market. OnMarch 24, 2020 , we entered into the Membership Interest Purchase Agreement ("Teco MIPA") which formalized the sale of the Teco Subsidiaries. Pursuant to the Teco MIPA, the Company will sell 100% of its membership interests in GBSN and GBLV for$4.0 million cash upon close and will receive a$4.0 million 8% promissory note to be paid in monthly installments over 36 months. The Company also holds aNevada license for cultivation of medical marijuana located inSandy Valley, Nevada (the "Nopah License"). The license is owned by the Company's wholly owned subsidiary,GB Sciences Nopah, LLC ("Nopah"). Operations have not begun under the Nopah License. OnAugust 10, 2020 , the Company entered into the Membership Interest Purchase Agreement ("Nopah MIPA") and Promissory Note Modification Agreement with the purchaser ofGB Sciences Nopah, LLC . As consideration for the transfer of the license and membership interest inGB Sciences Nopah, LLC , the Company will receive$300,000 and the purchaser will pay all expenses related to the upkeep and maintenance of the Nopah License. The sales of the Teco and Nopah licenses are expected to close upon the successful transfer of theNevada cultivation and production licenses. The transfer of cannabis licenses in theState of Nevada was subject to an indefinite moratorium beginning inOctober 2019 . In a meeting held onJuly 21, 2020 , the Nevada Cannabis Compliance Board ("CCB") lifted the moratorium, however the approval of the transfer has been delayed by a significant backlog of transfer applications. Based on recent communications with the CCB, the Company believes the hearing related to the transfers of interest will be scheduled for theDecember 2021 CCB meeting. The lifting of the moratorium and processing of cannabis license transfers have been delayed by the COVID-19 pandemic and could be further delayed if the pandemic worsens. 38
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Table of Contents
RESULTS OF OPERATIONS
The following table sets forth certain of our Statements of Operations data from
continuing operations:
For the Three Months Ended For the Six Months Ended
September 30, September 30,
2021 2020 2021 2020
General and administrative expenses
$ 904,951 $ 1,007,071 LOSS FROM OPERATIONS (411,545 ) (491,818 ) (904,951 ) (1,007,071 ) OTHER INCOME/(EXPENSE) Interest expense (95,244 ) (410,946 ) (160,498 ) (1,082,874 ) Debt default penalty - - - (286,059 ) Other income/(expense) 9,000 (1,750 ) 9,000 (3,374 ) LOSS BEFORE INCOME TAXES (497,789 ) (904,514 ) (1,056,449 ) (2,379,378 ) Income tax expense - - - - LOSS FROM CONTINUING OPERATIONS$ (497,789 ) $ (904,514 ) $ (1,056,449 ) $ (2,379,378 )
Comparison of the Three and Six Months Ended
General and Administrative Expenses
General and administrative expenses decreased by$(80,273) to$411,545 for the three months endedSeptember 30, 2021 , compared to$491,818 for the three months endedSeptember 30, 2020 . During the six months endedSeptember 30, 2021 , general and administrative expense decreased by$(102,120) to$904,951 , compared to$1,007,071 in the prior year. The decreases for the three and six months primarily relate to reduced compensation paid to executives and board members. The Company is continuing its efforts to maintain administrative costs at a minimum and to make the best use of its limited resources in advancing research & development of the Company's intellectual property portfolio. Interest Expense Interest expense decreased by$(315,702) to$95,244 for the three months endedSeptember 30, 2021 , compared to$410,946 in the prior year quarter. Interest expense decreased by$(922,376) to$160,498 for the six months endedSeptember 30, 2021 , compared to$1,082,874 in the prior year six months. The decrease is attributable to substantially less interest-bearing debt outstanding during the current year periods as the result of the payoff of the note payable toIliad Research and Trading, L.P. inDecember 2020 . In addition, notes with balances totaling$2.1 million atSeptember 30, 2021 are no longer accruing interest beginningDecember 1, 2020 , as the result of the Omnibus Amendment to the agreements surrounding the sale of the Company's Nevada Subsidiaries. Debt Default Penalty
The Company recorded a default penalty of
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Table of Contents
LIQUIDITY AND CAPITAL RESOURCES
Current Liquidity The Company will need additional capital to implement its strategies. There is no assurance that it will be able to raise the amount of capital needed for future growth plans. Even if financing is available, it may not be on terms that are acceptable. If unable to raise the necessary capital at the times required, the Company may have to materially change the business plan, including delaying implementation of aspects of the business plan or curtailing or abandoning the business plan. The Company represents a speculative investment and investors may lose all of their investment. In order to be able to achieve the strategic goals, the Company needs to further expand its business and financing activities. Based on the Company's cash position, it is necessary to raise additional capital by the end of the next quarter in order to continue to fund current operations. These factors raise substantial doubt about the ability to continue as a going concern. The Company is pursuing several alternatives to address this situation, including the raising of additional funding through equity or debt financing. In order to finance existing operations and pay current liabilities over the next twelve months, the Company will need to raise additional capital. No assurance can be given that the Company will be able to operate profitably on a consistent basis, or at all, in the future.
The principal sources of liquidity to date have been cash generated from sales of debt and equity securities and loans.
In continuing operations atSeptember 30, 2021 , cash was$395,325 , other current assets excluding cash were$220,241 , and our working capital deficit was$6,504,834 . Current liabilities in continuing operations were$7,120,400 and consisted principally of$1,584,985 in accounts payable,$1,734,959 in accrued liabilities,$3,715,543 in notes and convertible notes payable, and$84,913 in indebtedness to related parties. AtSeptember 30, 2021 , current assets from discontinued operations were$1,995,957 , current liabilities from discontinued operations were$1,725,013 , and working capital from discontinued operations was$270,944 . AtMarch 31, 2021 , continuing operations included a cash balance of$793,040 , other current assets excluding cash were$256,251 , and our working capital deficit was$5,494,572 . Current liabilities in continuing operations were$6,543,863 , which consisted principally of$1,412,459 in accounts payable,$1,451,687 in accrued liabilities,$3,594,804 in notes and convertible notes payable, and$84,913 of indebtedness to related parties. AtMarch 31, 2021 , current assets from discontinued operations were$2,494,564 , current liabilities from discontinued operations were$2,054,585 , and working capital from discontinued operations was$439,979 . 40
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Table of Contents Sources and Uses of Cash Operating Activities Net cash used in operating activities was$772,461 , net of$16,243 provided by discontinued operations for the six months endedSeptember 30, 2021 , compared to cash used of$212,854 including$10,602 used in operating activities of discontinued operations for the six months endedSeptember 30, 2020 . We anticipate that cash flows from operations will be insufficient to fund business operations for the next twelve-month period. Accordingly, we will have to generate additional liquidity or cash flow to fund our current and anticipated operations. This will likely require the sale of additional common stock or other securities. There is no assurance that we will be able to realize any significant proceeds from such sales, if at all. Investing Activities During the six months endedSeptember 30, 2021 ,$101,502 was provided by investing activities, including$1,502 provided by discontinued operations. Cash provided by investing activities of continuing operations consisted of$200,000 received by the Company as an advancement of the purchase price of the Teco facility, and was offset by$100,000 paid to acquire intangible assets. During the six months endedSeptember 30, 2020 , cash provided by investing activities was$597,658 , which consists of$701,923 in proceeds from a note receivable offset by$104,265 used in investing activities of discontinued operations. Financing Activities During the six months endedSeptember 30, 2021 , cash flows provided by financing activities totaled$44,729 , net of$67,931 used in discontinued operations. Cash flows provided by financing activities of continuing operations related to$62,660 in gross proceeds from warrant exercises and$50,000 proceeds of a convertible note payable. Cash provided by financing activities for the six months endedSeptember 30, 2020 was$157,671 , net of$101,487 used in discontinued operations. Cash provided by financing activities of continuing operations for the six months endedSeptember 30, 2020 consisted of$151,202 in proceeds from warrant exercises,$150,000 in proceeds of a note payable, and$125,000 of proceeds from a line of credit, offset by$15,121 of brokerage fees for warrant exercises and$151,923 of principal payments on a note to a related party. Going Concern The Company's financial statements have been prepared assuming the Company will continue as a going concern. The Company has sustained net losses since inception, which have caused an accumulated deficit of$105,237,521 atSeptember 30, 2021 . The Company had a working capital deficit of$6,233,890 atSeptember 30, 2021 , net of working capital of$270,944 classified as discontinued operations, compared to$5,054,593 atMarch 31, 2021 , net of working capital of$439,979 classified as discontinued operations. In addition, the Company has consumed cash in its operating activities of$772,461 for the six months endedSeptember 30, 2021 , net of$16,243 provided by discontinued operations, compared to$212,854 used in operating activities, net of$(10,602) provided by discontinued operations for the six months endedSeptember 30, 2020 . These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. Management has been able, thus far, to finance the losses through a public offering, private placements and obtaining operating funds from stockholders. The Company is continuing to seek sources of financing. There are no assurances that the Company will be successful in achieving its goals. Furthermore, Management believes the COVID-19 pandemic may have a significant impact on the Company's business. The pandemic presents a risk to the global economy, and it is possible that it could have an impact on the operations of the Company in the near term that could materially impact the Company's financials and ability to continue as a going concern. Management has not been able to measure the potential financial impact on the Company and continues to monitor the impact of the pandemic closely, although the extent to which the COVID-19 outbreak will impact our operations, financing ability or future financial results is uncertain. In view of these conditions, the Company's ability to continue as a going concern is dependent upon its ability to obtain additional financing or capital sources, to meet its financing requirements, and ultimately to achieve profitable operations. Management believes that its current and future plans provide an opportunity to continue as a going concern. The accompanying financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that may be necessary in the event the Company is unable to continue as a going concern. 41
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Table of Contents VARIABLES AND TRENDS In the event the Company is able to obtain the necessary financing to progress with its business plan, the Company expects expenses to increase significantly to grow the business. Accordingly, the comparison of the financial data for the periods presented may not be a meaningful indicator of future performance and must be considered in light of these circumstances. CRITICAL ACCOUNTING POLICIES A description of the Company's significant accounting policies is included in Note 3 of its Annual Report on Form 10-K for the fiscal year endedMarch 31, 2021 .
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