+Added: Company Segments
+Added: We operate through two segments, Infrastructure and Life Sciences.
+Added: The Infrastructure segment, based in India involves, the execution of construction projects, the purchase and resale of physical commodities used in infrastructure, and the rental of heavy construction equipment.
+Added: Our revenue in Fiscal 2020 was primarily derived from this segment.
+Added: The Life Sciences segment, previously referred to as the Plant and Cannabinoid Business, is based in the United States (“U.S.”) and Colombia South America.
+Added: It includes a biotech component, and a vertically integrated hemp-cannabinoid based healthcare and wellness business.
+Added: The Company operates through several subsidiaries and in Fiscal 2020 worked on bringing several brands to market.
+Added: We are a Maryland corporation established in 2005 with a fiscal year that is the 52- or 53-week period that ends on March 31.
Company Background
−Removed: IGC has two lines of business:
−Removed: 1) infrastructure, and 2) plant and cannabinoid-based products and therapies.
−Removed: The Company’s infrastructure business, based in India and Hong Kong involves (a) the rental of heavy construction equipment like bulldozers, excavators, rollers and pavers, among others;
−Removed: (b) execution of construction contracts;
−Removed: and (c) the purchase and resale of physical commodities used in infrastructure, like steel, marble and tiles (collectively, the “Infrastructure Business”).
−Removed: Our revenue in Fiscal 2019 was primarily derived from this business.
−Removed: Information about our infrastructure products and service offerings is available at www.igcinc.us.
−Removed: Our second line of business (collectively, the “Plant and Cannabinoid Business”) stems from plant extracts, including cannabinoids, produced by the cannabis plant (“phytocannabinoids”).
−Removed: Our plant and cannabinoid-based products and therapies involve several brands that the Company develops and expects to commercialize.
−Removed: The Company’s flagship branded, patent pending, product is Hyalolex™, a cannabinoid based alternative therapy, aimed at helping improve the quality of life for elderly patients suffering from dementia including Alzheimer’s disease (AD).
−Removed: Other alternative therapies in development include therapies for neuropathic pain, Parkinson’s disease (PD) and other Central Nervous System (CNS) disorders, among others.
−Removed: Hyalolex™ is based on a patent filing made by the University of South Florida for the use of ultra-low doses of cannabinoids for the treatment of AD.
−Removed: Further information is available at www.igcpharma.com and www.hyalolex.com.
−Removed: In addition, the Company, under the brand name Holi Hemp™, sells hemp crude extract, hemp isolate, and hemp distillate, among others.
−Removed: Further information is available at www.holihemp.com.
−Removed: The cannabis plant includes a variety commonly known as marijuana, and a variety known as hemp.
−Removed: These plants all produce, in varying degrees, molecules such as Tetrahydrocannabinol (THC), a molecule that mimics anandamide, a cannabinoid naturally produced by the human body, that creates a sense of euphoria.
−Removed: THC is the psychoactive molecule in cannabis.
−Removed: The cannabis plant also produces many other cannabinoids.
−Removed: Among them, cannabidiol (CBD) is a non-psychoactive molecule, which is the target of medical research.
−Removed: Under the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), Hemp is classified as a cannabis plant that has THC below 0.3% by dry weight and marijuana is classified as a cannabis plant that has THC above 0.3% by dry weight.
−Removed: As of March 31, 2019, the Company had the following direct operating subsidiaries:
−Removed: Techni Bharathi Private Limited (TBL), IGCare LLC, Holi Hemp LLC and IGC Pharma LLC.
−Removed: The Company’s fiscal year is the 52- or 53-week period that ends on March 31.
−Removed: The Company is a Maryland corporation established in 2005.
−Removed: The Company’s filings are available on www.sec.gov.
−Removed: Business Strategy
−Removed: Our strategy for the Infrastructure Business is to a) continue to rent heavy equipment to agricultural and construction contractors;
−Removed: b) invest in and competitively bid on constructions contracts, for example to build roads, bridges, and other civil works in Kerala India;
−Removed: and c) buy and sell infrastructure commodities.
−Removed: The Company expects to expand this line of business with the purchase of heavy equipment, bank guarantees, and an increase in employees and consultants.
−Removed: With respect to the Company’s second line of business, the Company’s strategy is to create, build, and manage several brands of plant and cannabinoid-based therapies, such as Hyalolex™, Serosapse™, Natrinol™ and products under Holi Hemp™, among others.
−Removed: As part of this strategy, the Company expects to secure its supply chain by setting up facilities that grow, process and extract hemp.
−Removed: If market demand for cannabinoids, such as CBD and full spectrum hemp oil (an extraction of the whole plant), grows, as predicted by some analysts, we expect to sell these products on a retail and wholesale basis.
−Removed: In addition, we are also exploring acquisitions, investments, or the creation of joint ventures with competitive and complementary businesses, products and technologies.
−Removed: The Company believes that ongoing and expanded investment in clinical trials, Research and Development (R&D), facilities, marketing and advertising, as well as the acquisition of products and businesses supporting our Plant and Cannabinoid Business, is critical to the development and delivery of innovative products and best in class patient experience.
−Removed: Our strategy for plant and cannabinoid-based alternative therapy and products is to leverage our R&D and our intellectual property, to develop unique products that are best in class, well differentiated and backed by science through planned pre-clinical and clinical trials.
−Removed: This strategy in some cases may lead to perceived improvements in existing products and the creation of new products in others, which, based on scientific study and research, we expect may offer positive results for the treatment of certain conditions, symptoms and/or side effects.
−Removed: Our longer-term strategy is to seek pharmaceutical status for our therapies by filing Investigative New Drug Applications (INDA) with the Food and Drug Administration (FDA) and conducting large medical trials.
−Removed: F iscal 2019 H ighlights
−Removed: ● On October 12, 2018, the Company filed a provisional patent with the United States Patent and Trademark Office (“USPTO”) for a CBD-infused energy drink titled “Method and Composition for Relieving Fatigue and Restoring Energy”.
−Removed: There can be no guarantee that the USPTO will grant the patent.
−Removed: ● On October 29, 2018, the NYSE suspended trading of IGC’s common stock and commenced proceedings to delist the Company’s stock from trading on the Exchange.
−Removed: The Company challenged the proposed delisting through the NYSE’s appeal procedures.
−Removed: On February 20, 2019, a unanimous review panel set aside the decision to delist IGC’s stock.
−Removed: On February 26, 2019 IGC’s stock was relisted on the NYSE American.
−Removed: ● During Fiscal 2019, the Company completed the development of its Quick Response (QR) code-based, Hyperledger-blockchain-based Product Identification and Assurance system (PIA).
−Removed: We expect to deploy the PIA system on our products in Fiscal 2020 to help with product identification, product origin assurance, collection of customer feedback, and surveying of customers.
−Removed: ● On November 6, 2018, the Company received notification from the United States Patent and Trademark Office (USPTO) of the patent issuance (#10,117,891) for its cannabinoid method and composition for the treatment of neuropathic pain in patients with Psoriatic Arthritis, Fibromyalgia, Scleroderma and other conditions.
−Removed: The formulation consists of the cannabinoids THC and CBD as well as other ingredients.
−Removed: The formulation for relieving pain is expected to be marketed under the brand Natrinol™.
−Removed: ● In Fiscal 2019, the Company completed a public offering of 5,898,656 shares listed on the NYSE American.
−Removed: The net proceeds from this transaction after underwriting discounts and commissions were approximately $28.5 million.
−Removed: The Company also issued 869,565 shares amounting to approximately $1 million pursuant to a private placement.
−Removed: ● In Fiscal 2019, we incorporated three wholly owned U.S.
−Removed: based subsidiaries:
−Removed: IGC Pharma LLC, that will own our intellectual property, and conduct R&D and medical trials;
−Removed: and IGCare LLC, that will commercialize;
−Removed: and Holi Hemp LLC, that will wholesale and retail, certain plant and cannabinoid-based products and therapies.
−Removed: ● On March 23, 2019, we sold our Malaysian subsidiary Cabaran Ultima and received back 80,000 shares of IGC common stock from the buyer of Cabaran.
−Removed: There was no operating activity or gain and loss in the subsidiary in Fiscal 2019.
−Removed: ● Based on the passage of the 2018 Farm Bill in December 2018, which legalized hemp in the U.S., the Company launched certain hemp products and therapies.
−Removed: o On March 22, 2019, the Company launched its website for hemp-derived products such as, hemp crude extract, hemp distillate, and hemp isolate under the brand Holi Hemp™.
−Removed: o On March 27, 2019, Hyalolex™, became available for purchase in select dispensaries in San Juan, Puerto Rico.
+Added: At IGC we are dedicated to pioneering the future of pharmaceuticals and wellness products through groundbreaking, innovative research in cannabinoid and hemp sciences.
+Added: Devastating diseases such as Alzheimer’s, Parkinson’s, Epilepsy, and chronic pain collectively affect over a billion people worldwide.
+Added: We believe life-altering solutions are within the reach of the current generation by applying creative concepts, dedicated study, a passion for community, and wellness empowerment, to cutting edge research, technology, and product development.
+Added: We believe that wellness and access to affordable, naturally derived therapies, and efficacious products and medicines is a human right and that hemp derived cannabinoids are a significantly viable alternative to many current medications.
+Added: Hemp itself is an impressively sustainable plant, and early anecdotal evidence suggests cannabinoid and hemp sciences may open doors to novel solutions for numerous diseases currently believed to be without a cure or without significant treatment options.
+Added: At IGC we resolve to not only create and make available cannabinoid-based formulations, but to work towards changing current stigmas around hemp so that these medicines can be made available to the people who need them most.
+Added: Since 2014, our team has been committed to researching the application of cannabinoids in combination with other compounds to address various ailments, using our research to develop intellectual property, formulations, and multiple wellness and lifestyle brands.
+Added: In Fiscal 2020, we were awarded a patent for our novel cannabinoid-based formulation addressing cachexia and eating disorders in humans.
+Added: This followed our Fiscal 2019 award of a patent for our formulation addressing pain.
+Added: Since 2014, the Company has also filed eight other patents to address various diseases such as seizures, eating disorders, fatigue, and stammering, among others.
+Added: In Fiscal 2020, we filed an Investigative New Drug Application (“INDA”) with the FDA for a double-blind, placebo-controlled, 100-person trial for treating patients suffering from Alzheimer’s disease with our patent pending cannabinoid formulation Hyalolex™ Drops of Clarity™.
+Added: In the long term we hope our efforts in cannabinoid-based Life Sciences segment lead to affordable, yet powerful, medications that can change lives;
+Added: elevating, and empowering the wellbeing of the communities we serve.
+Added: Our efforts since 2014, combined with the legalization of hemp through the 2018 Farm Bill, have created potentially large opportunities in hemp and cannabinoid science, which we intend to capture by creating a vertically integrated company.
+Added: In order to ensure trustworthy products of the highest quality, in Fiscal 2020 we took steps to internalize processes including growing hemp from which our cannabinoids are derived and setting up a processing facility that we expect will be operational in Fiscal 2021.
+Added: Additionally, we established a new production facility where we can make legal, hemp-based, cannabinoid-infused, products.
+Added: These products are expected to be sold under several of our brands.
+Added: Patent Activity
+Added: As part of our intellectual property strategy, we seek appropriate patent protection for applicable product candidates, drug delivery systems, and molecular modifications, as well as other proprietary technologies and their uses, by filing patent applications in the U.S.
+Added: and select other countries.
+Added: We intend for these patent applications to cover, where possible, claims for medical uses, processes for preparation, and processes for delivery and formulations.
+Added: We have also applied for approximately 26 trademarks under various classes.
+Added: The Company holds all rights to the patents that have been filed by us with the USPTO.
+Added: In Fiscal 2017, the Company also acquired exclusive rights to the data and the patent filing from University of South Florida (“USF”).
+Added: Although the Company believes the registration of patents is an important part of its business strategy and its success depends in part on such registration, the Company cannot guarantee that such patent filings will result in a successful registration with the United States Patent and Trademark office (“USPTO”).
+Added: Please see Item 1A, Risk Factors- “We may not successfully register the provisional patents with the USPTO”.
+Added: The table below provides a status of our patent filings:
+Added: Provisional Filing
+Added: Patent issued on 11/06/2018 (#10,117,891)
+Added: Eating Disorders
+Added: Patent issued on 03/24/2020
+Added: (#10,596,159 B2)
+Added: Eating Disorders
+Added: Alzheimer’s Disease
+Added: Anticipated in Fiscal 2021
+Added: CNS Disorders
+Added: Fatigue and energy restoration
+Added: Stammering, Tourette’s syndrome
+Added: Anticipated in Fiscal 2021
Products & Services
−Removed: Infrastructure Business
−Removed: Our Infrastructure Business, based in India and Hong Kong, involves:
−Removed: The rental of heavy construction equipment including bulldozers, excavators, rollers, and pavers, to contractors.
−Removed: This business involves a fleet of equipment that TBL owns, maintains and operates.
−Removed: The business is seasonal and is primarily active during the non-monsoon season.
−Removed: The business is dependent on infrastructure projects that the government implements;
−Removed: Bidding and execution of construction contracts;
−Removed: Our subsidiary TBL, with over 30 years of experience with infrastructure projects, recently began work on building and modifying a road in Kerala, India.
−Removed: In January 2019, TBL received a construction contract for the building of a National Highway Authority of India (“NHAI”)-sponsored local highway for approximately $0.6 million.
−Removed: This is a line that the Company expects to expand with the purchase of heavy equipment, bank guarantees, and an expanded team.
−Removed: TBL is currently executing this contract and expects to recognize revenue in Fiscal 2020;
−Removed: The purchase and resale of physical commodities used in infrastructure including steel, marble and tiles.
−Removed: Plant and Cannabinoid Business :
−Removed: We focus on the development and commercialization of plant and cannabinoid-based products and therapies.
−Removed: None of our plant and cannabinoid-based products or therapies are FDA-approved pharmaceuticals.
−Removed: Cannabinoids are chemical compounds that, based on various scientific studies and research, show various effects on the body and behavior.
−Removed: For example, a study 1 by Prof.
−Removed: Krista Lanctot presented at Neurology Live-2018, in Chicago, showed that synthetic THC exerts a range of effects on behavior, including improvement in agitation and cognitive behavior, in patients suffering from AD.
−Removed: Several other studies have indicated that cannabinoids exhibit anti-inflammatory properties and, may alleviate diarrhea, abdominal pain, and loss of appetite.
−Removed: Phytocannabinoids are cannabinoids that occur naturally in the cannabis plant.
−Removed: Phytocannabinoids are abundant in the viscous resin produced by glandular structures called trichomes.
−Removed: There are over 480 different compounds in the cannabis plant.
−Removed: Many of them have been identified as cannabinoids.
−Removed: Of these, THC is the main psychoactive component in the plant with many believed therapeutic uses.
−Removed: The other broadly pursued non-psychoactive phytocannabinoid is CBD.
−Removed: Both THC and CBD are pleiotropic i.e.
−Removed: studies indicate they may influence multiple pathways in humans, dogs and cats, and are believed to provide relief to a variety of symptoms including pain, seizures, and eating disorders.
−Removed: In medical applications, cannabinoids are extracted from the plant using a variety of well-established technologies, including using solvents such as CO2, Butane, and alcohol, among others.
−Removed: The refined extracted material is isolated for specific active ingredients, such as THC and CBD, among others, and is used in formulations as the primary or secondary active ingredient.
−Removed: Hyalolex™ is not approved by the FDA, and it is not considered a pharmaceutical drug.
−Removed: The name Hyalolex™, is based on the Greek roots hyalo and lex that broadly mean clear, clarity and/or glass-like, and words and/or reading, respectively.
−Removed: In AD cell lines, AD animal models, and in some human studies, the active ingredients in Hyalolex™ have been shown to alleviate many of the symptoms associated with AD.
−Removed: 2 Patients with AD may suffer from a variety of symptoms, including anxiety, agitation, dementia, and sleep disorder, among others.
+Added: Infrastructure s egment
+Added: We have been operating the Infrastructure segment since 2008 and our revenue in Fiscal 2020 was primarily derived from this segment:
+Added: a) Execution of Construction Contracts – The Company is executing a road building contract in Kerala, India valued initially at approximately $0.6 million.
+Added: Throughout Fiscal 2020, the Company worked on execution of the contract as well as sought approval for an expansion of the contract.
+Added: The total value of the contract was increased to approximately $1.1 million.
+Added: The Company estimates that it will take between 12 and 15 months to complete the work.
+Added: Work on this project has been temporarily suspended due to COVID-19.
+Added: We expect to re-start the project in the second quarter of Fiscal 2021.
+Added: b) Purchase and Resale of Physical Commodities Used in Infrastructure – This business line includes the purchase and resale of infrastructure materials including steel, wooden doors, marble, and tiles, among others.
+Added: This work has been adversely affected due to COVID-19.
+Added: c) Rental of Heavy Construction Equipment – We own heavy construction equipment such as motor grader, transit mixers and rollers, that we rent to construction contractors.
+Added: This business is seasonal and had minimal revenue during Fiscal 2020.
+Added: Life Science s segment
+Added: This segment is a) dedicated to research on cannabinoids and their efficacy on diseases and ailments, and b) the creation, marketing, and sales of cannabinoid-based wellness and lifestyle brands.
+Added: In Fiscal 2020, we advanced the development of several brands, building out our “house of brands” that we intend to market online and through retail stores in accordance with applicable laws and regulations.
+Added: We are enthusiastic about the potential of these concepts to address various segments of the growing cannabinoid wellness and lifestyle product market.
+Added: In Fiscal 2020, the Company generated $411 thousand revenue from its Life Sciences segment, however COVID-19 has forced the Company to delay the launch of some of the brands and products.
+Added: In Fiscal 2020 the Company, in response to the COVID-19 pandemic, adapted its manufacturing facility to include FDA-registered alcohol-based hand sanitizers, which go on sale in Fiscal 2021.
+Added: The Company’s hand sanitizer products are available under the brands:
+Added: Hyalolex™ and Camas Naturals™.
+Added: In Fiscal 2020, we expanded the Hyalolex™ brand from the original formulation of Hyalolex™ Drops of Clarity™ , to include CBD infused tinctures, intended as aids for sleep disorders, stress, and other ailments, as well as offering traditional and hemp-infused hand sanitizers.
+Added: Hyalolex™ Drops of Clarity™, which remains our flagship product, is not an FDA-approved pharmaceutical drug.
+Added: It is currently sold in Puerto Rico through dispensaries.
+Added: The name Hyalolex™, is based on the Greek roots “hyalo” which can be interpreted as clarity, being clear or glass-like, and “lex” referring to reading or words, respectively.
+Added: The original formulation of Hyalolex™ Drops of Clarity™ is based on work that was done at USF that filed a patent that we acquired and continued to pursue by responding to queries by the USPTO in Fiscal 2020.
+Added: The research performed by USF indicated that in Alzheimer’s cell lines, Alzheimer’s animal models, and in some human studies, the active ingredients in Hyalolex™ Drops of Clarity™, may effectively alleviate many of the symptoms associated with Alzheimer’s.
+Added: The research and cell data indicated a reduction in the aggregation of ® amyloid protein (“A® protein”) that deposits senile plaque between neurons, leading to interference with intra-neuronal signaling1.
+Added: The research also showed a reduction in Neurofibrillary Tangles (“NFTs”) by reducing the hyperphosphorylation of microtubule-associated protein Tau that leads to neuronal death.
+Added: Plaques and NFTs are the hallmarks of Alzheimer’s.
+Added: Patients with Alzheimer’s disease may suffer from a variety of Behavioral and Psychological Symptoms of Dementia (“BPSD”) including anxiety, agitation, dementia, depression, and sleep disorder, among others.
These symptoms often result in hard-to-manage patients and caregiver distress.
−Removed: 1 Hasenoehrl C., et al.
−Removed: 2 Cao, et al.
−Removed: “The Potential Therapeutic Effects of THC on Alzheimer’s Disease.” Journal of Alzheimer’s Disease.
−Removed: Our research into plant and cannabinoid-based combination therapies led us to studies performed at the University of South Florida (USF) using cannabinoids on AD.
−Removed: The professor working on this approach was featured on CNN on Dr.
−Removed: Sanjay Gupta’s show Weed 3.
−Removed: The work, specifically, reported several findings that were subsequently filed as a patent that we refer to as IGC-AD1.
−Removed: In Fiscal 2017, we acquired exclusive rights to the data and the patent filing from USF.
−Removed: The research reported that micro-dosing of the cannabinoid THC, in combination with other naturally occurring compounds, works synergistically to reduce the buildup of plaques and tangles, through allegedly new pathways.
−Removed: These results were shown using Alzheimer’s cell lines.
−Removed: Plaques and tangles are hallmarks of AD.
−Removed: Studies have demonstrated that patients get plaques and tangles around 15 to 20 years before any AD related symptoms such as dementia manifest.
−Removed: The studies further showed, on Alzheimer’s cell lines, that micro dosing of cannabinoids in combination with other naturally occurring compounds can increase the functioning of mitochondria.
−Removed: The findings are unique as previous research into cannabinoids showed the opposite effect at higher doses, for example, loss of mitochondrial functioning.
−Removed: We believe that the novelty is two-fold:
−Removed: first, that micro dosing of THC affects the brain differently from higher dosing that is prescribed (FDA-approved Dronabinol, for example) or consumed by individuals;
−Removed: and second, that micro doses of THC can work synergistically with other naturally occurring compounds to increase efficacy and reduce side effects.
−Removed: For example, the research showed that at these therapeutic micro-doses, THC is non-toxic to neurons, a finding contrary to other research and data showing that THC is neuro-toxic at higher ingestion levels.
−Removed: The research was extended to include a Morris Water Maze test for measuring spatial memory impairment on transgenic Alzheimer’s mice.
−Removed: The research indicated that transgenic Alzheimer’s mice treated with cannabinoids at certain doses were significantly better at negotiating the water maze than untreated transgenic Alzheimer’s mice.
−Removed: As expected, neither group were anywhere close to the performance of healthy mice.
−Removed: Preliminary findings have also reported that low doses of THC can play a role in triggering neurogenesis, the growth and development of neuronal tissue.
−Removed: After further research and experiments, our team created Hyalolex™, an oral formulation as a syrup.
−Removed: QR code-based blockchain PIA
−Removed: Through consultancy relationships, the Company has developed, completed and expects to deploy a QR code-based, Hyperledger-blockchain-based PIA system that allows patients to access a website with information on our products, including where to buy the products.
−Removed: As the number of states in which the product is available increases, we hope to expand the information populating the backend to inputs directly from growers, processors and dispensaries.
−Removed: This information is intended to collectively display product identification and product origination by providing the patient with information regarding the origin, chemicals and processes used to manufacture the product.
−Removed: Serosapse ™ and Natrinol ™
−Removed: Other products that we are developing include Serosapse™ designed to assist in the treatment of certain indications of PD and other CNS disorders;
−Removed: and Natrinol™ designed to assist in the treatment of certain indications of neuropathic pain.
−Removed: The Company filed a patent application for Serosapse™ in March 2018.
−Removed: The Company received a patent for the formulation in Natrinol™ in November 2018.
−Removed: Neither of these products are FDA-approved, and they are not considered to be pharmaceutical drugs.
−Removed: We buy hemp crude extract, outsource the refinement of extract, and sell refined extracts such as hemp distillate and hemp isolate through our brand Holi Hemp™.
−Removed: The Company expects to secure its supply chain in Fiscal 2020 and beyond by investing in facilities that grow, process, and extract hemp.
−Removed: 3 Bilkei-Gorzo, et al.
−Removed: A chronic low dose of Δ 9 -tetrahydrocannabinol (THC) restores cognitive function in old mice.
−Removed: Nature Medicine.
+Added: Application of our formulation in animal studies using transgenic Alzheimer’s mice (mice with Alzheimer’s) showed an improvement in memory.
+Added: These exciting results led our team to create Hyalolex™ Drops of Clarity™ as an oral formulation.
+Added: As a next step, in Fiscal 2020, the Company filed an INDA with the FDA for a phase II double-blind, placebo-controlled, 100-person trial, for the formulation.
+Added: The trial will study the efficacy of the formulation on BPSD in patients suffering from Alzheimer’s.
+Added: The site for the Phase II study is expected to be Puerto Rico, where we purchased space in a hospital building for running the trial.
+Added: In order to assist with the global response to the COVID-19 pandemic, we created several formulations of hand sanitizers, compliant with the recommendations of the World Health Organization (“WHO”) and the Center for Disease Control (“CDC”) guidelines.
+Added: Our facility in Vancouver is registered with the FDA as are most of our hand sanitizer formulations.
+Added: Our liquid WHO formulations are hand rubs that can be used in hospitals and by first responders, while our gel formulations, infused with one or more ingredients including zinc oxide, hemp oil, lavender oil, lemon oil and Aloe Vera, are for commercial use.
+Added: In Fiscal 2020, we reported no revenue from hand sanitizers, as they went on sale in April 2020.
+Added: Hyalolex TM brand hand sanitizers are currently available for purchase online at www.hyalolexhandsanitizer.com .
+Added: In Fiscal 2020, we prepared our production facility to offer extraction, distillation, tolling, and white labeling services under the brand of Holi Hemp™.
+Added: However, due to COVID-19, we were unable to complete the commissioning of all the equipment.
+Added: We expect that when the equipment is commissioned, we will be vertically integrated in the hemp industry, where we can control the growing, processing and production of products.
+Added: We expect that the facility will also allow us to offer services such as extraction and distillation of biomass to hemp farmers.
+Added: 1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2813509/
+Added: Update on previously announced products
+Added: Natrinol™, previously named as a product for Pain, has been folded into the Holief™ brand.
+Added: The Company’s work on Serosapse™, previously named as a product for Parkinson's, has been put on hold as we work on other products and brands.
+Added: NO3A™, initially targeting the beverage industry, has been folded into Sunday Seltzer™.
+Added: Business Strategy
+Added: Our strategy for the Infrastructure segment is to invest in and competitively bid on construction contracts, for example to build roads, bridges, and other civil works in Kerala India, and to opportunistically buy and sell infrastructure and other commodities.
+Added: The Company currently lacks visibility into this business because the COVID-19 pandemic and stay-at-home / shelter in place orders have slowed down this industry.
+Added: We view our desire to be vertically integrated in the hemp industry as providing us with several profit opportunities that we expect to focus on in Fiscal 2021:
+Added: 1) sale of branded products, under the Herbo™, Hyalolex™, Camas Naturals™, Holief™ and Sunday Seltzer ™ product lines, among others;
+Added: 2) white labeling of products such as lotions, creams, oils, for other brands;
+Added: 3) wholesale of hemp extracts including hemp crude extract and hemp isolate, among others;
+Added: 4) processing of hemp biomass and crude oil for farmers in the Northwest U.S.
+Added: 5) sale of hand sanitizers.
+Added: Though the biotech part of our Life Sciences strategy will take longer for investors to see results, and carries more risk, this sector provides significantly greater defensible growth potential.
+Added: Tackling a disease like Alzheimer’s with cannabinoids may seem to be a bold endeavor, but we believe the evidence we have developed and obtained is compelling and merits exhaustive investigation and research.
+Added: We are dedicated to the cause, having filed patents, and an INDA with the FDA, as well as having established a trial center under contract with a team of experts in the field.
+Added: Our approach is to look at the efficacy for BPSD first, and, if successful turn our attention to the hallmarks of Alzheimer’s:
+Added: plaques and tangles.
+Added: We also believe that the ongoing and expanded investment in clinical trials, Research and Development (“R&D”), facilities, marketing and advertising, as well and the acquisition of products and businesses supporting our Life Sciences segment, is critical to the development and delivery of innovative products and best in class patient and customer experience.
+Added: Part of our strategy is to leverage our R&D and our intellectual property, to develop products that are well differentiated and backed by science through planned pre-clinical and clinical trials.
+Added: We believe this strategy has the potential to improve existing products and lead to the creation of new products, which, based on scientific study and research, in turn may offer positive results for the treatment of certain conditions, symptoms and/or side effects.
+Added: Fiscal 2020 Highlights
+Added: • The Company is executing a road building contract in Kerala, India valued initially at approximately $0.6 million.
+Added: Throughout Fiscal 2020, the Company worked on execution of the contract as well as sought approval for an expansion of the contract.
+Added: The total value of the contract was increased to approximately $1.1 million.
+Added: The Company estimates that it will take between 12 and 15 months to complete the work.
+Added: Work on this project has been temporarily suspended due to COVID-19.
+Added: We expect to re-start the project in second quarter of Fiscal 2021.
+Added: • The Company filed an INDA with the FDA for a double-blind, placebo-controlled, 100-person trial, for its proprietary patent pending formulation based on IGC-AD1 that uses ultra-low doses of tetrahydrocannabinol (“THC”) with other natural compounds intended to assist in the management of the care of patients suffering from Alzheimer’s disease.
+Added: • IGC filed a provisional patent, IGC 510, Compositions and Methods using CBD for treating stammering and symptoms of Tourette syndrome with the USPTO.
+Added: • The Company established an approximately $0.5 million facility in San Juan, Puerto Rico to house and conduct trials.
+Added: • As part of an out-reach and marketing campaign, we distributed samples of Hyalolex™ Drops of Clarity™, to dispensaries in Puerto Rico.
+Added: The formulation is currently available in about 51 dispensaries in Puerto Rico.
+Added: While this is a small market penetration, it allows us to collect data.
+Added: Based on feedback received from customers and dispensaries in Puerto Rico, the Company has expanded the scope of the Hyalolex™ formulation to potentially target other ailments, such as anxiety and sleep disorders, and has introduced a line of products including tinctures, among others.
+Added: These will all be branded under Hyalolex™, with the original formulation branded as Hyalolex™ Drops of Clarity™.
+Added: Post COVID-19 based stay-in-place restrictions we expect to manufacture and distribute these products initially in Puerto Rico and subsequently online and in other states.
+Added: • In Fiscal 2020 the Company in response to the COVID-19 pandemic adapted its manufacturing facility to include FDA-registered alcohol-based hand sanitizers, which go on sale in Fiscal 2021.
+Added: • The Company advanced its branding and product strategy with the development of several brands aimed at various sectors of the market.
+Added: The progress includes filing trademark applications and intent to use applications;
+Added: securing URLs;
+Added: creating product formulations, labelling, and packaging;
+Added: obtaining product insurance;
+Added: securing product development teams;
+Added: conducting focus groups;
+Added: performing quality and taste testing;
+Added: and organizing and registering limited liability companies to mitigate risk, among others.
+Added: • The Company grows hemp in Arizona.
+Added: The crop has passed inspection by the Arizona Department of Agriculture (“AZDA”) and has been certified as legal by AZDA.
+Added: However, the harvest is delayed due to of the difficulty in finding workers because of the social distancing rules brought on by COVID-19.
+Added: • We prepared our facilities in Washington for the dual purpose of manufacturing finished products as well as for extraction and distillation.
+Added: Most of our hemp processing and distillation equipment is sourced from China.
+Added: Currently, due to COVID-19 the commissioning and certification of the equipment is delayed as the technicians are unable to travel from China to the U.S.
+Added: • On February 15, 2020, the Company signed a Share Subscription Agreement (“SSA”) with Evolve I, to acquire 20% of Evolve I.
+Added: As of March 31, 2020, the Company has not completed its due diligence.
+Added: • IGC recently received notification that on March 24, 2020, the USPTO issued a method and composition patent (#10,596,159 B2) for the Company’s cannabinoid formulation for the treatment of cachexia and eating disorders in humans and veterinary animals.
+Added: IGC filed this application for its IGC-504 formulation (#15/751,901) on August 11, 2016.
Markets and Distribution
−Removed: Infrastructure Business
−Removed: For (a) the equipment rental business, we rent heavy equipment to construction companies, mostly located in Kerala, India.
−Removed: With respect to (b) bidding and executing of construction contracts;
−Removed: our subsidiary TBL, with over 30 years of experience with infrastructure projects recently began work on building and modifying a road in Kerala, India.
−Removed: In January 2019, TBL received a construction contract for the building of a National Highway Authority of India (“NHAI”) sponsored local highway for approximately $0.6 million.
−Removed: This is a line that the Company expects to expand with the purchase of heavy equipment, bank guarantees, and the retention of additional employees and consultants.
−Removed: TBL is currently executing this contract and expects to recognize revenue in Fiscal 2020, and with respect to (c) the purchase and resale of physical commodities, we purchase infrastructure materials and resell them.
−Removed: We neither hedge nor take long term positions on infrastructure commodities, and we limit our financial exposure by contractually ensuring that purchases have vetted buyers and settlement dates.
+Added: Infrastructure segment
+Added: The state of Kerala and the National Highway Authority of India publish Request for Proposals (RFP) with a Statement of Work (SOW) for the building of various infrastructure projects such as roads, bridges, by-passes, etc.
+Added: In Fiscal 2020, we focused on executing a construction project in the state of Kerala.
+Added: We also purchase and resell physical commodities that are used in the construction business by constructions companies.
+Added: In addition, we maintain a small fleet of heavy construction equipment in Kerala consisting of motor grader, transit mixers and rollers, etc., that is leased out to construction companies.
In Fiscal 2020, we have a total of 5 customers and 3 suppliers of infrastructure materials, which account for over 10% of sales and cost of sales.
−Removed: In Fiscal 2019, our suppliers are companies based in India and Hong Kong.
For the level of business, and the value of each trade, we believe that the number of customers we have does not constitute inordinate customer risk.
−Removed: The total revenue from our Infrastructure Business is less than 1% based on revenue of the rental, construction and infrastructure commodities markets.
−Removed: Plant and Cannabinoid Business
−Removed: AD has been referred to as America’s most expensive disease.
−Removed: The estimated cost to Medicare and Medicaid of AD and other dementias, as per the Alzheimer’s Association, is projected to be about $290 4 billion in 2019.
−Removed: It is estimated that there are currently over 5.8 million 4 Americans with AD and around 50 million 5 worldwide.
−Removed: The cost of AD is skyrocketing as the baby-boomers age:
−Removed: the number of AD patients is expected to double over the next 20 years, and the direct costs are expected to exceed $450 billion in the next 12 years.
−Removed: Although the rate of progression can vary, the average life expectancy following diagnosis is believed to be between three and nine years.
−Removed: It is the most common cause of dementia among older adults.
−Removed: Currently, no treatment can stop or reverse the progression of the disease, and there is still no accepted cure for AD.
−Removed: After launching Hyalolex™ in Puerto Rico, we expect to launch in other countries and certain states in the U.S.
−Removed: where we can legally enter the market.
−Removed: Hyalolex™ is formulated for a dose of 1 ml either two or three times a day.
−Removed: It is currently available in 30 ml bottles.
−Removed: To ensure compliance and product assurance, we propose to deploy a QR code-based, Hyperledger-blockchain-based, PIA system that will track the product and allow patients to access information about the product and provide feedback.
−Removed: Our plans for Hyalolex™ in Fiscal 2020 are to file an INDA with the FDA and commence to conduct a pivotal phase 2 trial using a protocol that currently targets measuring Behavioral and Psychological Symptoms of Dementia (BPSD) in patients suffering from AD.
−Removed: The Filing of an INDA with the FDA is no guarantee that the FDA will approve the application.
−Removed: 4 Alzheimer’s Association.
−Removed: “2019 Alzheimer’s disease facts and figures.” (2019)
−Removed: 5 https://www.brightfocus.org/alzheimers/article/alzheimers-disease-facts-figures
−Removed: Serosapse ™ and Natrinol ™
−Removed: The pain management market represents a significant component of the healthcare system.
−Removed: In September 2012, The Journal of Pain reported that the annual estimated national cost of pain ranges from $560 billion to $635 billion.
−Removed: This figure exceeds the entire cost of the nation’s priority health conditions.
−Removed: Additionally, the American Pain Society recommends that pain be made more visible and be categorized as the fifth vital sign, recognizing that terminal illnesses are often accompanied by unbearable levels of pain that are so severe and difficult to treat that death seems preferable.
−Removed: According to the Arthritis Foundation, arthritis has been particularly problematic for women.
−Removed: Since 1999 there has been a 22% increase in the number of women who attribute their disability to arthritis.
−Removed: Current treatment protocols such as the utilization of opioid-based drug therapies present several challenges and may result in debilitating consequences that affect patients’ day-to-day functioning and patients’ productivity.
−Removed: Commonly reported side effects include hallucinations, constipation, sedation, nausea, respiratory depression and dysphoria.
−Removed: Our patent filing is based on therapy that uses extracts from the cannabinoids plant for the treatment of psoriatic arthritis and scleroderma pain.
−Removed: The therapy uses a cream that is applied to the joints using a variety of delivery mechanisms, including a bio-adhesive patch.
−Removed: There are over one million adults suffering from PD in the U.S.
−Removed: PD is the second most common neurodegenerative disorder worldwide with an estimated 1% of adults over 60 suffering from the disease.
−Removed: The market for curing the disease is very large.
−Removed: We are testing products for end points associated with PD such as REM (Rapid Eye Movement) sleep disorder, anxiety, and dyskinesia.
−Removed: The PD treatment market is expected to reach $5.69 billion by 2022 from $4.24 billion in 2017, at a CAGR of 6.1% 6 .
−Removed: The market is being driven by the growth in aging population and the associated increase in the prevalence of PD and government funding for research.
−Removed: Approximately 50 million people worldwide are affected by epilepsy 7 .
−Removed: Epilepsy is thought to be due to multiple factors that include the alteration of many ion channels such as sodium, potassium, NMDA (N-Methyl-d-aspartate) and neurotransmitters such as GABA (gamma amino butyric acid).
−Removed: It is believed, for example, that to maximally control epilepsy, modulation of one or more of these channels and receptors is required and that monotherapy is adequate in up to 25% of patients.
−Removed: The onset of epileptic seizures can be life threatening and lead to long-term implications 8 such as mental health problems, cognitive deficits and morphological changes.
−Removed: 9 The onset of epilepsy also greatly affects lifestyle as sufferers may live in fear of consequential injury or the inability to perform daily tasks.
−Removed: 10 The scientific community 11 has shown that CBD has anti-convulsive properties in humans.
−Removed: Other studies 12 have shown that micro-doses of THC can also help reduce seizures.
−Removed: Three of our patent filings involving therapies use phytocannabinoid extracts from cannabinoids, in combination with other generic drugs, to treat medical refractory epilepsy in humans and seizures in dogs and cats.
−Removed: Cachexia is a condition that accompanies severe illness, such as cancer, and may result in the weakness of the body.
−Removed: Cachexia may physically weaken patients to the extent that response to standard treatments is poor.
−Removed: In the U.S., it is estimated that a population of approximately 1.4 million 13 is experiencing cachexia associated with cancer, multiple sclerosis, PD, HIV/AIDS, and other progressive illnesses.
−Removed: Cachexia is secondary to an underlying disease such as cancer or AIDS and is a positive risk factor for death.
−Removed: As an example, cancer induced anorexia cachexia is responsible for about 20% of all cancer deaths.
−Removed: Our patent filing involves a therapy that uses phytocannabinoids in an effort to stimulate senses (smell and taste) with a combination of drugs to stimulate appetite.
−Removed: Our approach addresses the veterinarian market, as dogs and cats also suffer from pain, epilepsy, and cachexia, and getting a product to market for the veterinarian industry is significantly less time consuming than getting products approved for human healthcare.
−Removed: There are around 185 million domesticated dogs and cats in the U.S., and about 1% of dogs and 2% of cats suffer from seizures.
−Removed: 6 https://www.marketsandmarkets.com/PressReleases/parkinson-disease-treatment.asp
−Removed: 7 World Health Organization.
−Removed: 9 Swann, 2004, Avoli et.
−Removed: 10 Fisher et.
−Removed: 11 1980 Cunha et.
−Removed: al., 1986 Ames, 1990 Trembly et.
−Removed: recent testing by GW Pharmaceuticals, among others
−Removed: 12 Davis and Ramsey
−Removed: 13 Cachexia, survival and the acute phase response.
−Removed: Stephens NA, Skipworth RJ, Fearon KC.
−Removed: Current Opinion Support Palliative Care.
−Removed: 14 Review Cancer anorexia-cachexia syndrome:
−Removed: current issues in research and management.
−Removed: (Inui A CA Cancer J Clin.
−Removed: 2002 Mar-Apr;
−Removed: 52(2):72-91.) and Norleena P.
−Removed: Gulletta, Vera Mazurakb, Gautam Hebbarc, and Thomas R.
−Removed: Ziegler, Nutritional Interventions for Cancer-induced Cachexia.
−Removed: Curr Probl Cancer.
−Removed: The Company intends to sell its plant and cannabinoid-based products including hemp oil, hemp distillate and isolate, among others under the brand name Holi Hemp™.
+Added: However, there has been a marked disruption of the Hong Kong economy which combined with the impact of COVID-19 on our operations is reflected in reduced revenue and increased expenses in our infrastructure business in last quarter of Fiscal 2020.
+Added: The total revenue from our Infrastructure Business is less than 1% of the global revenue of the rental, construction, and infrastructure commodities markets.
+Added: Life Science s segment s
+Added: Our brands are designed to address different demographics and segments of the market.
+Added: For example, Sunday Seltzer™ addresses the infused seltzer market.
+Added: Herbo™ addresses the spa and wellness market.
+Added: Holief™ addresses the pain market.
+Added: Hyalolex™ began as a single product brand and now has several products that address specific conditions and diseases and in Fiscal 2020, the original Hyalolex™ formulation, now known as Hyalolex™ Drops of Clarity™, was available through licensed dispensaries in Puerto Rico.
+Added: The Company filed an INDA with the FDA for a double-blind, placebo-controlled, 100-person trial, for its proprietary patent pending formulation based on IGC-AD1 that uses ultra-low doses of THC with other natural compounds intended to assist in the management of the care of patients suffering from Alzheimer’s disease.
+Added: In Fiscal 2020, we have one supplier of raw materials and no customers, which accounts for over 10% of sales and cost of sales.
+Added: In Fiscal 2020, our suppliers are companies based in the U.S.
+Added: and Hong Kong.
Since the legal hemp industry in the U.S.
is new, we neither have a major supplier nor dependence on a major customer.
−Removed: For the level of business and the value of each trade, the number of customers we have is adequate and does not constitute inordinate customer risk.
−Removed: Revenue from our Holi Hemp™ products is less than 1% based on revenue of markets.
+Added: The COVID-19 pandemic has and might continue to affect our operations and that could be reflected in reduced revenue and increased costs in our Life Sciences segment.
+Added: Revenue from our Life Sciences is less than 1% based on revenue of global markets.
+Added: sales of cannabis and hemp-derived CBD products are expected to increase from $1.9 billion in 2018 to $20 billion by 2024, a compound annual growth rate (“CAGR”) of 49%.
+Added: When combined with THC products, the CBD market is expected to create a total market of $45 billion for cannabinoids by 2024 2 .
+Added: The global CBD skin care market size was valued at $234.1 million in 2018 and is expected to expand at a CAGR of 32.9% from 2019 to 2025 3 .
+Added: Overall revenue in the Skin Care segment amounts to about $18 billion in the U.S.
+Added: The market is expected to grow annually by 3.5% (CAGR 2020-2023).
+Added: The market is primarily driven by growing awareness with respect to the benefits of CBD infused personal care products.
+Added: Cannabis infused drink market is also expected to reach $1.4 billion by 2024.
+Added: Further, it is estimated that 535,000 acres of land was licensed for hemp production in the U.S.
+Added: in 2019, leading to an estimate of between 96 and 120 million pounds of CBD rich hemp biomass suitable for extraction.
+Added: Business Seasonality
+Added: The Company has historically experienced seasonality in the Infrastructure segment based on low work in construction during the monsoon season.
+Added: As most of the harvest in America occurs in the fall, there tends to be pricing pressure based on the volume of hemp biomass being harvested.
+Added: 2 https://bdsa.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024/
+Added: 3 https://www.grandviewresearch.com/industry-analysis/cbd-skin-care-market?utm_source=prnewswire.com&utm_medium=referral&utm_campaign=PRN_Aug29_cbdskincare_CMFE_RD2&utm_content=Content
+Added: 4 https://www.statista.com/outlook/70020000/109/skin-care/united-states
+Added: 5 https://www.cannabisbusinesstimes.com/article/us-cannabis-drinks-market-2024/
+Added: Wholesale Hemp Price Benchmarks
Research and Development
−Removed: In Fiscal 2019 and Fiscal 2018, IGC identified combinations of micro-doses of THC and the non-psychoactive compound CBD to address symptoms of PD and other diseases.
−Removed: The costs associated with this work is mostly internal research, such as, looking for combinations of plant extracts that could work and data to support the claims that certain combinations and formulations can alleviate symptoms associated with diseases.
−Removed: In Fiscal 2019 we incorporated IGC Pharma LLC to consolidate and continue to conduct R&D.
−Removed: The amount spent for R&D is approximately $1.3 million and $137 thousand in Fiscal 2019 and Fiscal 2018, respectively.
−Removed: All R&D costs are expensed in the period in which they are incurred.
+Added: Our success is based on our ability to innovate and bring unique products to market that address specific needs.
+Added: We spent about $1 million and $1.3 million in Fiscal 2020 and Fiscal 2019, respectively.
+Added: In Fiscal 2020 our R&D included products such as Sunday Seltzer™, FDA trials for Hyalolex™ Drops of Clarity™ and several new products for pain, among others.
+Added: We expect to spend resources on R&D as we conduct research on the benefits of various cannabinoids.
Some of the markets for the Company’s products and services are highly competitive, and some are not, as described below:
−Removed: Infrastructure Business :
+Added: Infrastructure segment:
This business is currently limited to India and Hong Kong.
−Removed: The infrastructure industry is highly competitive, and we believe our differentiation is based primarily on price and industry knowledge of construction and commodity requirements for infrastructure projects.
−Removed: In Fiscal 2019, apart from working capital, the Company invested $300 thousand in TBL, to bid on construction contracts.
−Removed: While competition is strong, we expect demand for infrastructure projects to again increase with the newly elected Indian government once again focusing on infrastructure.
−Removed: Plant and Cannabinoid Business :
−Removed: In the U.S., there is very little widespread research on phytocannabinoids, with most of the research concentrated in Israel and Canada.
−Removed: This is largely because the U.S.
−Removed: Drug Enforcement Administrating (DEA) classifies phytocannabinoid extracts such as THC as a Schedule 1 drug.
−Removed: This means that phytocannabinoids are characterized as substances with “high potential for abuse” and with “no currently accepted medical use.” We believe our differentiation from our competitors, for example, in the use of phytocannabinoids for the treatment of AD, is based primarily on our data, patent filings, experienced team, and early-mover advantage.
−Removed: Core b usiness c ompetencies and advantages
+Added: The infrastructure industry is highly competitive, and we believe our differentiation is based primarily on price and industry knowledge of construction and commodity requirements for infrastructure projects in the areas in which we operate.
+Added: Life Sciences segment:
+Added: We are focused on developing affordable FDA approved medical products that can help individuals suffering from debilitating disease like Alzheimer’s and chronic pain, among others.
+Added: We believe our differentiation from our competitors, for example, in the use of phytocannabinoids for the treatment of Alzheimer’s, is based primarily on our data, patent filings, and experienced team, offering us an early-mover advantage.
+Added: We face competition from well-funded seasoned companies.
+Added: On the healthcare and wellness side, we face competition from companies that are better established in wholesale products such as hemp crude extract, hemp isolate and services such as white labelling and tolling.
+Added: On the product side we face competition from companies in the food, beverage, and skin care industries.
+Added: It is unclear how the FDA guidance and ruling on CBD-infused food products, when it is released, will impact the market.
+Added: Despite the passage of the 2018 Farm Bill, the FDA has not set out guidance or rules on the infusion of CBD into food and beverage products.
+Added: While this has and continues to create a complicated framework within which we navigate, we anticipate that when such rules are set out, the demand for CBD will increase as major food and beverage manufacturers will enter the market.
+Added: Core business competencies and advantages
Our core competencies include the following:
• a network of doctors, PhDs, and intellectual property legal experts that have a sophisticated understanding of drug discovery, research, FDA filings, intellectual protection, and product formulation;
−Removed: • knowledge of various cannabinoids strains, their phytocannabinoid profile, extraction methodology and impact on various pathways;
+Added: • knowledge of various cannabinoid strains, their phytocannabinoid profile, extraction methodology, and impact on various pathways;
• knowledge of plant and cannabinoid-based combination therapies;
• knowledge of research and development in the field;
−Removed: • Patent IGC-501 for cannabinoids and pain has been issued.
−Removed: Technology, Cybersecurity and Intellectual Property
−Removed: The success of most of our product candidates will depend in large part on our ability to:
−Removed: • penetrate and create a market for our products,
−Removed: • obtain and maintain patent and other legal protections for the proprietary technology, inventions and improvements we consider important to our business;
−Removed: • prosecute our patent applications and defend our issued patents;
−Removed: • preserve the confidentiality of our trade secrets;
−Removed: • operate without infringing the patents and proprietary rights of third parties.
−Removed: On October 12, 2018, the Company filed a provisional patent with the USPTO for a CBD-infused energy drink titled “Method and Composition for Relieving Fatigue and Restoring Energy.” There can be no guarantee that the USPTO will grant the patent.
−Removed: We intend to continue to seek appropriate patent protection for certain of our product candidates, drug delivery systems, and molecular modifications, as well as other proprietary technologies and their uses, by filing patent applications in the U.S.
−Removed: and selected other countries.
−Removed: We intend for these patent applications to cover, where possible, claims for medical uses, processes for preparation, processes for delivery and formulations.
−Removed: We have intellectual property attorneys that file patents or provisional patent applications, copyrights, trademark and trade secret laws of general applicability, employee confidentiality and invention assignment agreements.
−Removed: We also expect to deploy a QR code-based PIA and other intellectual property protection methods to safeguard our technology and research and development.
−Removed: All our data, except accounting data, is stored in the cloud on multiple servers that helps us mitigate the overall risk of losing data.
+Added: • patent IGC-501 and IGC-504 for treatment of pain and treatment of cachexia and eating disorders in humans and veterinary animals, respectively;
+Added: • a team with experience in manufacturing, marketing, and selling cannabinoid products.
+Added: Licenses, Technology and Cybersecurity
+Added: We have intellectual property attorneys that advise, counsel, and represent the Company regarding the filing of patents or provisional patent applications, copyrights applications and trademark applications;
+Added: trade secret laws of general applicability;
+Added: employee confidentiality and invention assignment.
+Added: Most of our data, including our accounting data, is stored in the cloud that helps us mitigate the overall risk of losing data.
We have a cybersecurity policy in place and are in the process of implementing tighter cybersecurity measures to safeguard against hackers.
−Removed: We expect to implement these measures in Fiscal 2020.
The Company holds all rights to the patents that have been filed by us with the USPTO.
−Removed: Although, the Company believes the registration of patents is an important part of its business strategy and its success depends in part on such registration, the Company cannot guarantee that such patent filings will result in a successful registration with the USPTO.
−Removed: Please see Item 1A, Risk Factors- “We may not successfully register the provisional patents with the USPTO”.
−Removed: The table below provides a status of our patent filings:
−Removed: Provisional Filing
−Removed: Subsequent Activity
−Removed: Patent notification received on 11/6/2018 (#10,117,891)
−Removed: National Case Filed on 6/15/16
−Removed: PCT Application Published on 10/6/16
−Removed: Eating Disorders
−Removed: and National Filing on 2/12/18
−Removed: National Filing Anticipated on in 2019
−Removed: Eating Disorders
−Removed: and National Filing Anticipated on 8/28/19
−Removed: Alzheimer’s Disease
−Removed: Anticipated in 2019
−Removed: and National Filing Anticipated in 2019
−Removed: CNS Disorders
−Removed: Anticipated in 2019
−Removed: and National Filing Anticipated in 2019
−Removed: Fatigue and energy restoration
−Removed: Anticipated in 2019
−Removed: and National Filing Anticipated in 2019
−Removed: Stammering, Tourette’s syndrome
−Removed: Anticipated in 2020
−Removed: and National Filing Anticipated in 2020
The table below summarizes the nature of activity, type of license required and held, and encumbrances in obtaining permits for each location where the company operated through its subsidiaries in Fiscal 2020:
4 unchanged sentences
Obtaining Permit
−Removed: Plant and cannabinoid-based products and General Management
+Added: Life Sciences products and General Management
General business.
−Removed: License to grow and process hemp.
+Added: License to grow and transport hemp.
+Added: Industrial Alcohol User Permit
+Added: Clinical Trials
General business licenses.
−Removed: Applied for a license to grow and process hemp.
+Added: License to grow and transport hemp.
+Added: Industrial Alcohol User Permit
+Added: Clinical Trials
Infrastructure Contract, Rental of heavy equipment and land
6 unchanged sentences
we are subject to oversight and regulations, for some or all of our activities, by the following agencies:
−Removed: SEC, state regulators, NYSE, and the FDA.
−Removed: As mentioned above, the cannabis plant consists of several strains or varieties.
+Added: SEC, state regulators, NYSE, FTC, and the FDA.
+Added: The cannabis plant consists of several strains or varieties.
Hemp and Marijuana are both cannabis plants.
4 unchanged sentences
It contains provisions that make industrial hemp legal.
−Removed: Although, effective January 1, 2019, hemp is legal at the federal level, most states are only now creating appropriate licensing and testing processes for the growing, processing, and sale of hemp and hemp-derived products.
−Removed: For our business we must apply for licenses in states where we desire to grow and process hemp, for example, in the state of Arizona, where we plan on growing and processing hemp, we are required to apply for licenses and register with the state the geo-location of all our operations, including the land on which hemp is grown and the facilitates where hemp will be processed.
+Added: Although, effective January 1, 2019, hemp is legal at the federal level, most states have created licensing and testing processes for the growing, processing, and sale of hemp and hemp-derived products.
+Added: For our business we must apply for licenses in states where we desire to grow and process hemp.
+Added: For example, in the state of Arizona, where we grow hemp, we are required to apply for licenses and register with the state the geo-location of all our operations, including the land on which hemp is grown and the facilitates where hemp will be processed.
These regulations are evolving, differ from jurisdiction to jurisdiction, and are subject to change.
50 unchanged sentences
After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter.
−Removed: A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application.
+Added: A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, for the FDA to reconsider the application.
If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.
11 unchanged sentences
Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of the clinical trial is made public as part of the registration.
−Removed: Under a new rule, effective January 18, 2017, sponsors are also obligated to disclose the results of these trials after completion.
Disclosure of the results of these trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year.
61 unchanged sentences
Employees and Consultants
−Removed: As of March 31, 2019, we employed 20 full-time employees.
−Removed: These numbers include the Infrastructure Business and the Plant and Cannabinoid Business.
−Removed: We also have contract workers and advisors in the U.S., India, and Hong Kong.
−Removed: Reclassification, merger, consolidation, or purchase or sale of a significant amount of assets
−Removed: Certain prior period amounts in the consolidated financial statements and accompanying notes have been reclassified to conform to the current period’s presentation.
−Removed: Certain aged receivables and certain deposits and advances in the amount of approximately $644 thousand have been reclassified to non-current assets from current assets.
−Removed: In Fiscal 2019, a Note Payable in the amount of $1.8 Million has been paid off.
−Removed: Please see “Note 10 – Loans and Other Liabilities,” in our Notes to Consolidated Financial Statements contained herein for more information.
−Removed: In Fiscal 2018 we exited our non-operational Hong Kong subsidiary IGC Cleantech Ltd, and in Fiscal 2019 we exited our Malaysian subsidiary Cabaran.
+Added: As of March 31, 2020, we employed a team of approximately 50 full-time employees in our two segments.
+Added: We also have contract workers and advisors in the U.S., India, Colombia, and Hong Kong.
Available Information
7 unchanged sentences
Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only.
+Added: IGC maintains several Internet addresses including www.igcinc.us, www.holihemp.com , www.hyalolex.com and www.herbo.com , among others.
+Added: These, including our Twitter @IGCIR and other social media contain information about IGC and our products on these websites from time to time, as we plan to provide updates on the company, announcements regarding relevant research findings and patent approval, and other important information as we grow and expand.
+Added: Website and social media references in this report are provided as a convenience and do not constitute, and should not be viewed as, incorporation by reference of the information available through, or contained on, the websites and in social media.
+Added: Therefore, such information should not be considered part of this report.
+Added: The Company’s filings with the SEC are accessible on SEC’s website, www.sec.gov .
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.