The following discussion and analysis contains "forward-looking statements," as defined in
the United StatesPrivate 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 of GB Sciencesproducts, 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 the Securities 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 with United Statesgenerally accepted accounting principles. You should read this discussion and analysis together with such financial statements and the related notes thereto. Overview GB 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-inspired medicines, with virtual operations in North Americaand Europe. 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 programs are in the pre-clinical 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-human trial. Depending on the results of ongoing preclinical studies, the Company intends to move forward with clinical trials for its chronic pain and COVID-related cytokine release syndrome therapies 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 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 the State of Delawareon April 4, 2001, under the name " Flagstick Venture, Inc." On March 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. On April 4, 2014, we changed our name from Signature Exploration and Production Corporationto Growblox Sciences, Inc.Effective December 12, 2016, the Company amended its Certificate of Corporation pursuant to shareholder approval, and the Company's name was changed from Growblox Sciences, Inc.to GB Sciences, Inc.
Table of Contents Plan of Operation
Drug discovery and development of new cannabis 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 the Natural Sciences and Mathematics Departmentat Chaminade 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 Labat 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. The U.S. Patent and Trademark Officeallows 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. 28
Table of Contents Drug Development Progress
GBS 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-human clinical trial. GBSGB's chronic pain, anxiety, and depression formulations are currently in preclinical animal studies with Dr. Lee Ellisof the National Research Council("NRC") Canadain Halifax, 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 Kaminskiat Michigan 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 the US FDAto 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 billionin the U.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 on US FDA-approved, cannabinoid-containing drugs, their Schedule I drug manufacturing facilities, their familiarity with US FDAand 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 in Halifax, 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 on August 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 at Michigan State Universityusing 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. 29
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 reach
USD 19.81 Billionby 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 with Chaminade University, 2) GBSGB's Cannabis Metabolomics Projectwith both Chaminade Universityof Honolulu, Hawai'i and the University of Athens, Greece, and 3) GBSGB's Applied Time-Released Nanoparticles for Delivery of Cannabis-based Ingredients with the University of Seville, Spainand the University 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 of U.S.Patent No. 10,653,640 entitled "Cannabinoid-Containing Complex Mixtures for the Treatment of Neurodegenerative Diseases" on May 19, 2020protects 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 $560and $650 billion dollars, and an estimated 20.4% of U.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 ComplexMixtures 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 the U.S. Food and Drug Administration'sexpedited approval process, which allows clinically successful treatments to get to market both quicker and more cost effectively. Gaining approval from the US FDAfor 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. 30
Intellectual property portfolio
GBSGB retained Fenwick & West, a
Silicon Valleybased 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: COMPLEX MIXTURES CONTAINING CANNABINOIDS 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: COMPLEX MIXTURES CONTAINING CANNABINOIDS FOR THE TREATMENT OF INFLAMMATORY DISORDERS ASSOCIATED WITH MAST CELLS OR BASOPHIL MEDIATION
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, LLCthese 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,
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. 31
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,
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
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 32
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.
The GBSGB currently has ongoing research agreements with the following institutions covering the research areas indicated:
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 the University of Athens, Greeceand 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 Sevillehas 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 the University of Sevilleare 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 from Sevilleare very promising, and these nanoparticles have entered the animal testing phase at the NRC in Halifax. The National Research Center(NRC) of Canada, 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.
Path to Market: Proposed Drug Development Stages and 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 obtaining
US FDApre-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-Human 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 obtain US FDAapproval 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. 34
Table of Contents Other Operations On
March 24, 2020, the Company entered into the Membership Interest Purchase Agreement ("Teco MIPA") with AJE Management, LLC. Pursuant to the Teco MIPA, the Company agreed to sell 100% of its membership interests in GB Sciences Nevada, LLC, and GB Sciences Las Vegas, LLC(the "Teco Subsidiaries") for approximately $8 million, which amount includes a cash payment at closing, the extinguishment of certain liabilities owed to the purchaser and affiliates of the purchaser, and an 8% promissory note. On August 10, 2020, the Company entered into the Membership Interest Purchase Agreement ("Nopah MIPA") and Promissory Note Modification Agreement with 483 Management, LLC. Pursuant to the Nopah MIPA, the Company agreed to sell its 100% membership interest in GB Sciences Nopah, LLC("Nopah"), which holds a Nevadamedical marijuana cultivation certificate. As consideration, the Company would receive $300,000as a reduction to the balance of the 0% Note payable dated October 23, 2017(Note 4) and accounts payable of $74,647, which were owed to an affiliate of the purchaser. The closing of the Teco and Nopah sales was contingent upon the successful transfer of the Nevadacultivation and production licenses. On December 14, 2021, the Company received approval from the Nevada Cannabis Compliance Board for thetransfer of cannabis cultivation and extraction licenses held by its subsidiaries GB Sciences Nevada, LLC, GB Sciences Las Vegas, LLC, and GB Sciences Nopah, LLC(the "Nevada Subsidiaries"). Consequently, all conditions to closing the sales of the 100% membership interests in the Nevada Subsidiaries were satisfied, and the transactions formally closed on December 31, 2021. After the closing date, the Company retains no ownership interest in the NevadaSubsidiaries. 35
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 Nine Months Ended December 31, December 31, 2021 2020 2021 2020
General and administrative expenses
$ 1,417,738 $ 1,677,482LOSS FROM OPERATIONS (512,788 ) (670,311 ) (1,417,738 ) (1,677,482 ) OTHER INCOME/(EXPENSE) Interest expense (159,478 ) (167,120 ) (319,976 ) (1,249,994 ) Gain on extinguishment - 467,872 - 467,872 Gain on deconsolidation 5,206,208 - 5,206,208 - Gain on settlement of accounts payable - 372,415 - 372,415 Loss on amendment to line of credit - (650,000 ) - (650,000 ) Debt default penalty - - - (286,059 ) Other income/(expense) (15,639 ) 17,523 (6,639 ) 14,149 INCOME/(LOSS) BEFORE INCOME TAXES 4,518,303 (629,621 ) 3,461,855 (3,009,099 ) Income tax expense - - - -
INCOME/(LOSS) FROM CONTINUING OPERATIONS
Comparison of the three and nine month periods ended
General and administrative expenses
General and administrative expenses decreased by
$(157,523)to $512,788for the three months ended December 31, 2021, compared to $670,311for the three months ended December 31, 2020. During the nine months ended December 31, 2021, general and administrative expense decreased by $(259,744)to $1,417,738, compared to $1,677,482in 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 $(7,642)to $159,478for the three months ended December 31, 2021, compared to $167,120in the prior year quarter. Interest expense decreased by $(930,018)to $319,976for the nine months ended December 31, 2021, compared to $1,249,994in 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 to Iliad Research and Trading, L.P.in December 2020. In addition, notes with balances totaling $2.1 millionat December 31, 2021stopped accruing interest beginning December 1, 2020, as the result of the Omnibus Amendment to the agreements surrounding the sale of the Company's Nevada Subsidiaries. Gain on Extinguishment During the three and nine months ended December 31, 2020, the Company recorded a gain on extinguishment of $467,872related to the settlement of the note payable to Iliad Research and Trading, L.P.at a discount. Gain on Deconsolidation During the three and nine months ended December 31, 2021, the Company recorded a gain on deconsolidation of $5,206,208as the result of the sale of the NevadaSubsidiaries. 36
Gain on settlement of accounts payable
During the three and nine months ended
December 31, 2020, the Company recorded gains totaling $372,415related to the settlement with vendors of accounts payable for less than the full balance owed. The full amount owed to each vendor was accrued in accounts payable during prior periods.
Loss on line of credit modification
During the three and nine months ended
December 31, 2020, the Company recorded $650,000in expense related to the December 29, 2020modification of the July 24, 2020Line of Credit payable to AJE Management, LLCas the result of the Omnibus Amendment agreement. Debt Default Penalty The Company recorded a default penalty of $286,059for the nine months ended September 30, 2020, related to the Company's failure to timely repay the principal and interest owed under the note payable to Iliad Research and Trading, L.P.on April 1, 2020. The penalty was 10% of the principal and accrued interest balances outstanding at the time of default.
CASH 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 primary sources of cash to date have been cash generated from the sale of debt and equity securities and loans as well as the sale of our subsidiaries.
December 31, 2021, cash was $1,504,330, other current assets excluding cash were $112,347, and our working capital deficit was $3,022,261. Current liabilities in continuing operations were $3,802,198and consisted principally of $1,735,905in accounts payable, $472,812in accrued liabilities, $1,508,568in notes and convertible notes payable, and $84,913in indebtedness to related parties, and a current liability from discontinued operations of $836,740, which represents a federal income tax liability generated by the Teco Subsidiaries. At March 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 $1,412,459in accounts payable, $1,451,687in accrued liabilities, $3,594,804in notes and convertible notes payable, and $84,913of indebtedness to related parties. At March 31, 2021, current assets from discontinued operations were $2,494,564, current liabilities from discontinued operations were $761,509, and working capital from discontinued operations was $1,201,488. 37
Table of Contents Sources and Uses of Cash Operating Activities Net cash used in operating activities was
$1,200,915, including $87,772used by discontinued operations for the nine months ended December 31, 2021, compared to cash used of $1,253,180, net of $21,098provided by operating activities of discontinued operations for the nine months ended December 31, 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 nine months ended December 31, 2021, $1,550,339was provided by investing activities, including $1,567provided by discontinued operations. Cash provided by investing activities of continuing operations consisted of $1,648,772proceeds received from the sale of the Nevada Subsidiaries, and was offset by $100,000paid to acquire intangible assets. During the nine months ended December 31, 2020, cash provided by investing activities was $4,594,621, which consists of $5,051,923in proceeds from a note receivable, offset by $326,000paid to acquire intangible assets and $131,302used in investing activities of discontinued operations. Financing Activities During the nine months ended December 31, 2021, cash flows provided by financing activities totaled $9,273, net of $103,387used in discontinued operations. Cash flows provided by financing activities of continuing operations related to $62,660in gross proceeds from warrant exercises and $50,000proceeds from a convertible note payable. Cash used in financing activities for the nine months ended December 31, 2020was $2,571,850, including $129,237used in discontinued operations. Cash used in financing activities of continuing operations for the nine months ended December 31, 2020consisted of $3,156,014of principal payments on notes and convertible notes payable, a principal payment of $151,923on a note payable to a related party, $34,500fees for issuing convertible notes payable, and $24,983brokerage fees for issuance of common stock and warrants, offset by $249,807gross proceeds from warrant exercises, $300,000proceeds from convertible notes payable, and $375,000proceeds from a line of credit. 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 $100,911,984at December 31, 2021. The Company had a working capital deficit of $3,022,261at December 31, 2021, including a tax liability of $836,740from discontinued operations, compared to $5,054,593at March 31, 2021, net of working capital of $1,201,488classified as discontinued operations. In addition, the Company has consumed cash in its operating activities of $1,200,915for the nine months ended December 31, 2021, including $87,772used by discontinued operations, compared to $1,253,180used in operating activities, net of $21,098provided by discontinued operations for the nine months ended December 31, 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. 38
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 ended
March 31, 2021.
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