GB SCIENCES INC Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-Q)

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The following discussion and analysis contains "forward-looking statements," as
defined in the 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 of GB 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
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 States generally 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 America and 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 Delaware on 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
Corporation to 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.



Effective April 8, 2018The shareholders of the Company approved the change of registered office of the State of Delaware to the state of nevada and increasing the number of authorized capital shares from 250,000,000 to 400,000,000. Effective August 15, 2019The shareholders of the Company approved an increase in the authorized share capital from 400,000,000 to 600,000,000.

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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
Department at 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 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.



The U.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.



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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
Ellis of the National Research Council ("NRC") Canada in 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 Kaminski at 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 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 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 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 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 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.



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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 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
with Chaminade University, 2) GBSGB's Cannabis Metabolomics Project with both
Chaminade University of 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, Spain and 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, 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% 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 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 the U.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 the US 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.



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Intellectual property portfolio




GBSGB retained Fenwick & West, a Silicon 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: 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.

we Patent protection has been granted for complex mixtures containing GBSGB cannabinoids for the treatment of Parkinson’s disease.




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 we for use in the treatment of pain related to arthritis, shingles, irritable bowel syndrome, sickle cell disease and endometriosis.

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.

we Patent protection has been granted for complex mixtures containing GBSGB cannabinoids for the treatment of mast cell activation syndrome (MCAS).





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 

SevilleUniversity of

                     29, 2017                           Cadiz, Centro de 

Investigation

                                                        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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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, 

NC,

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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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, 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 the University 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
from Seville are 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.



University of Hawaii: Validation of the efficacy of a complex cannabis-based mixture for the treatment of cardiac hypertrophy and heart disease in a rodent model. Proof of concept work is complete in rodents and we are looking for commercialization partners.




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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 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-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 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.



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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 Nevada
medical marijuana cultivation certificate. As consideration, the Company would
receive $300,000 as 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 Nevada cultivation and production licenses. On December 14,
2021, the Company received approval from the Nevada Cannabis Compliance Board
for the transfer 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 Nevada
Subsidiaries.



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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 $512,788 $670,311

    $   1,417,738     $  1,677,482
LOSS 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 $4,518,303 ($629,621) $3,461,855 ($3,009,099)

Comparison of the three and nine month periods ended December 31, 2021 and 2020

General and administrative expenses




General and administrative expenses decreased by $(157,523) to $512,788 for the
three months ended December 31, 2021, compared to $670,311 for 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
$1,677,482 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 $(7,642) to $159,478 for the three months ended
December 31, 2021, compared to $167,120 in the prior year quarter. Interest
expense decreased by $(930,018) to $319,976 for the nine months ended December
31, 2021, compared to $1,249,994 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 to Iliad
Research and Trading, L.P. in December 2020. In addition, notes with balances
totaling $2.1 million at December 31, 2021 stopped 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 $467,872 related 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 $5,206,208 as the result of the sale of the Nevada
Subsidiaries.



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Gain on settlement of accounts payable




During the three and nine months ended December 31, 2020, the Company recorded
gains totaling $372,415 related 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
$650,000 in expense related to the December 29, 2020 modification of the July
24, 2020 Line of Credit payable to AJE Management, LLC as the result of the
Omnibus Amendment agreement.



Debt Default Penalty



The Company recorded a default penalty of $286,059 for 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.




At  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 $3,802,198 and consisted principally
of $1,735,905 in accounts payable, $472,812 in accrued liabilities, $1,508,568
in notes and convertible notes payable, and $84,913 in 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 $1,412,459 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. 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.



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Sources and Uses of Cash



Operating Activities



Net cash used in operating activities was $1,200,915, including $87,772 used by
discontinued operations for the nine months ended December 31, 2021, compared to
cash used of $1,253,180, net of $21,098 provided 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, $1,550,339 was provided by
investing activities, including $1,567 provided by discontinued operations. Cash
provided by investing activities of continuing operations consisted of
$1,648,772 proceeds received from the sale of the Nevada Subsidiaries, and was
offset by $100,000 paid to acquire intangible assets. During the nine months
ended December 31, 2020, cash provided by investing activities was $4,594,621,
which consists of $5,051,923 in proceeds from a note receivable, offset by
$326,000 paid to acquire intangible assets and $131,302 used 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 $103,387 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 from a
convertible note payable. Cash used in financing activities for the nine months
ended December 31, 2020 was $2,571,850, including $129,237 used in discontinued
operations. Cash used in financing activities of continuing operations for
the nine months ended December 31, 2020 consisted of $3,156,014 of principal
payments on notes and convertible notes payable, a principal payment of $151,923
on a note payable to a related party, $34,500 fees for issuing convertible notes
payable, and $24,983 brokerage fees for issuance of common stock and warrants,
offset by $249,807 gross proceeds from warrant exercises, $300,000 proceeds from
convertible notes payable, and $375,000 proceeds 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 $100,911,984 at December
31, 2021. The Company had a working capital deficit of $3,022,261 at December
31, 2021, including a tax liability of $836,740 from discontinued operations,
compared to $5,054,593 at March 31, 2021, net of working capital of $1,201,488
classified as discontinued operations. In addition, the Company has consumed
cash in its operating activities of $1,200,915 for the nine months ended
December 31, 2021, including $87,772 used by discontinued operations, compared
to $1,253,180 used in operating activities, net of $21,098 provided 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.



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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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