What changed in this filing

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Item 1. Business

2021-06-14 compared with 2020-07-13 · 232 added, 187 removed, 218 unchanged (66% of the section changed)

Company Segments

We operate through two segments, Infrastructure and Life Sciences.

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.

Our revenue in Fiscal 2020 was primarily derived from this segment.

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.

It includes a biotech component, and a vertically integrated hemp-cannabinoid based healthcare and wellness business.

The Company operates through several subsidiaries and in Fiscal 2020 worked on bringing several brands to market.

Company Overview

Since 2014, our team has been committed to researching the application of cannabinoids such as Tetrahydrocannabinol (“THC”) and Cannabidiol (“CBD”) in combination with other compounds to address various ailments, including Alzheimer's disease.

With our research, we have developed intellectual property, formulations, and wellness and lifestyle brands.

In fiscal year ended March 31, 2021 (“Fiscal 2021”), we were awarded a patent for our cannabinoid-based formulation treatment of seizures in humans and veterinary animals.

This followed our fiscal year ended March 31, 2019 (“Fiscal 2019”) and fiscal year ended March 31, 2020 (“Fiscal 2020”) awards of patents for our formulation addressing pain and formulation addressing Cachexia and eating disorders, respectively.

Since 2014, the Company has also filed nine other patent applications to address various diseases such as Alzheimer's, pain, stammering, seizures, eating disorders, and fatigue, among others.

Our goal is to bring products to market based on our intellectual property (“IP”) in one of three channels:

We are developing a range of products for the pharmaceutical markets which are subject to FDA-approved clinical trials.

We currently have one investigational product in clinical trials under an INDA filed with the FDA.

We are currently developing branded wellness and lifestyle products intended to be sold in diverse retail channels subject to Federal laws in the U.S.

Finally, we will be seeking partnerships and licensing agreements with third parties who we anticipate will provide a clear route to market our IP.

In the Pharmaceutical channel, we created a patent-pending formulation based on ultra-low dosing of THC in combination with other compounds that, in 2021, under an INDA filed with the FDA, underwent the first stage of a phase 1 trial on safety and tolerability.

The phase 1 trial is ongoing at the time of this filing.

We are motivated by the potential that, with future successful results from appropriate further trials, IGC-AD1 could contribute to relief for some of the 50 million people around the world expected to be impacted by Alzheimer's disease by 2030 (WHO, 2020).

Data from pre-clinical studies, including cell lines and animal models, showed the formulation, IGC-AD1, inhibited the accumulation of the neurotoxic protein beta-amyloid (“Aβ”) that leads to the buildup of plaques, as well as the hyperphosphorylation of protein Tau that leads to Neuro Fibrillary Tangles (“NFT”) two of the hallmarks of Alzheimer's disease.

In pre-clinical studies, certain combinations of IGC-AD1 also showed memory improvement and neurogenesis.

Our lead cannabinoid-based investigational drug is based on a pharmaceutical formulation comprising of purified plant-derived THC for which we have filed several patent applications and acquired rights to other patent applications.

Following the conclusion of our phase 1 trial, and the evaluation of its results, we hope to initiate phase 2 trials to obtain efficacy data for Behavioral and Psychological Symptoms of Dementia (“BPSD”) and to evaluate IGC-AD1 for additional indications such as anxiety and sleep disorders.

In addition, our pipeline of pharmaceutical formulations includes cannabinoid product candidates for pain and various potential targets within central nervous system disorders.

For the Retail Channel, in Fiscal 2021, we developed wellness and lifestyle brands, Holief™, Herbo™, and Sunday Seltzer™.

We plan on marketing these brands, including to the U.S.

based Latino market, which is among the fastest-growing segment in the U.S.

GDP, that in 2018 was around $2.6 Trillion.

(Forbes, 2020).

It is projected that the Hispanic population will reach 111.22 million by 2060 from 59 million in 2018 (Statista, 2021).

Holief, which includes our patented cream, is a brand focused on alleviating and reducing pain symptoms.

It includes, among other products, targeted products for women suffering from period pain.

Information is available on www.holief.com.

Herbo is a premium hemp-based CBD infused organic topical and spa line of products targeting the wellness market.

The products, CBD infused body lotion, body butter, and others, all carry a signature fragrance that was developed by us.

Information is available on www.herbo.com.

Sunday Seltzer is a premium hemp-based CBD infused seltzer that is available in several flavors including grapefruit, lemon, blackberry, cucumber, ginger, and passion fruit.

The products are all low- or no-calorie beverage options available in select stores in New Jersey as well as online.

For more information, please visit www.sundayseltzer.com.

All of our cannabinoid-based product lines are pursued in accordance with all applicable federal, state, and local laws and regulations.

We also operate an infrastructure segment, managed from India, that involves the execution of construction projects, the purchase and resale of physical commodities mostly used in infrastructure, and the rental of heavy construction equipment.

During and as a result of the COVID-19 pandemic, this segment slowed down considerably.

We anticipate returning to pre-pandemic-level operations in this line of business when the pandemic allows.

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

At IGC we are dedicated to pioneering the future of pharmaceuticals and wellness products through groundbreaking, innovative research in cannabinoid and hemp sciences.

Devastating diseases such as Alzheimer’s, Parkinson’s, Epilepsy, and chronic pain collectively affect over a billion people worldwide.

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.

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.

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.

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.

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.

In Fiscal 2020, we were awarded a patent for our novel cannabinoid-based formulation addressing cachexia and eating disorders in humans.

This followed our Fiscal 2019 award of a patent for our formulation addressing pain.

Since 2014, the Company has also filed eight other patents to address various diseases such as seizures, eating disorders, fatigue, and stammering, among others.

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™.

In the long term we hope our efforts in cannabinoid-based Life Sciences segment lead to affordable, yet powerful, medications that can change lives;

elevating, and empowering the wellbeing of the communities we serve.

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.

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.

Additionally, we established a new production facility where we can make legal, hemp-based, cannabinoid-infused, products.

These products are expected to be sold under several of our brands.

Patent Activity

COVID-19 Update

As our infrastructure business is based in Asia (India and Hong Kong), the COVID-19 pandemic and restrictions imposed by governmental entities adversely impacted, and continues to adversely impact, our financial condition, liquidity, and operations.

In Fiscal 2021, we experienced substantially reduced revenue from Infrastructure segment.

We anticipate that reduced revenue from Infrastructure segment will continue in Fiscal 2022 as the pandemic continues to affect the regions where we do business.

In particular, during Fiscal 2021:

Our revenue from the infrastructure business was adversely affected with increased expenses.

We are executing a road building contract in Kerala, India valued at approximately $1.2 million.

Work on this project is sporadic based on COVID-19 restrictions.

In response to the COVID-19 pandemic, we manufactured and distributed alcohol-based hand sanitizers.

The majority of our revenue for Fiscal 2021 is from the sale of hand sanitizers.

In an effort to help some of the hardest hit communities, we donated hand sanitizers to the Federal Emergency Management Agency (“FEMA”), the Navajo Nation in Arizona, the Crow reservation in Montana, and the Sioux reservation in South Dakota.

Due to the pandemic, we were unable to process our harvested hemp crop grown in Arizona because of difficulties associated with transportation and third-party processing.

Intellectual Property

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.

1 unchanged sentence

We intend for these patent applications to cover, where possible, claims for medical uses, processes for preparation, and processes for delivery and formulations.

We have also applied for approximately 26 trademarks under various classes.

The Company holds all rights to the patents that have been filed by us with the USPTO.

The Company holds all rights to the patents that have been filed by us with the United States Patent and Trademark office (“USPTO”).

In Fiscal 2017, the Company also acquired exclusive rights to the data and the patent filing from University of South Florida (“USF”).

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”).

Please see Item 1A, Risk Factors- “We may not successfully register the provisional patents with the USPTO.”

2 unchanged sentences

Patent issued on 11/06/2018 (#10,117,891)

Patent issued on 08/05/2020 (#10,751,300)

Eating Disorders

3 unchanged sentences

Alzheimer’s Disease

Anticipated in Fiscal 2021

CNS Disorders

1 unchanged sentence

Stammering, Tourette’s syndrome

CBD & Method for Treating Pain (2 nd )

Anticipated in Fiscal 2022

Stress relief & calm restoring beverage

Anticipated in Fiscal 2022

Alzheimer ’ s disease

According to the National Institute of Health’s National Institute on Aging (“NIA”), Alzheimer’s is an irreversible progressive brain disorder that destroys memory and thinking skills and, eventually the ability to carry out even the simplest of tasks.

Symptoms for most people may first appear for individuals at ages in their mid-60s.

Some experts believe that Alzheimer’s is the third leading cause of death just behind heart disease and cancer.

(NIA, 2019) According to the World Health Organization (“WHO”), Alzheimer’s is believed to cause about 60-70% of dementia, which is the loss of cognitive functioning that includes thinking, remembering, reasoning and behavioral abilities.

Alzheimer’s disease is expected to effect approximately 50 million people worldwide by 2030 (WHO, 2020).

According to the Alzheimer’s Association, approximately 10% of Americans over 65 have Alzheimer’s disease, and some researchers suspect that half of people over 80 develop Alzheimer’s (Piedmont Healthcare, (n.d);

Alzheimer’s Association, 2021).

While some researchers view Alzheimer’s as a spectrum disease (Devi, (n.d), the NIA categorizes Alzheimer’s in three stages - mild, moderate and severe (NIA, 2019).

Broadly, in mild Alzheimer’s, problems can include wandering;

getting lost, not remembering the way home for example;

trouble handling money and paying bills;

repeating questions;

and personality and behavior changes.

In moderate Alzheimer’s, there is damage to the areas of the brain that control language, reasoning, sensory processing, and conscious thought.

Problems can include difficulty carrying out multistep tasks such as dancing, getting dressed, and more behavior changes including hallucinations, delusions, paranoia, and impulsive behavior.

By the time severe Alzheimer’s sets in, plaques and tangles spread throughout the brain, and the brain shrinks significantly.

People with severe Alzheimer’s are completely dependent on others for care, they cannot communicate, and near the end, the body shuts down (NIA, 2019).

Alzheimer’s patients manifest BPSD that include, among others, depression, agitation, aggression, sleep disturbance (sundown syndrome), delusions, hallucinations, and anxiety.

These symptoms put a burden on caregivers that leads to caregiver distress (Cheng, 2017).

Our Phase 1 trial on IGC-AD1 has commenced on patients suffering from mild to severe dementia due to Alzheimer’s disease.

Phase 1 Trial updates

On July 30, 2020, we received a notice from the FDA to proceed with a 12-subject Phase 1 human clinical trial (“removal of full clinical hold”) on our INDA, submitted under Section 505(i) of the Federal Food, Drug, and Cosmetic Act, for our “IGC-AD1” proprietary formulation.

Our IGC-AD1 formulation is based on a patent filed by the University of South Florida (“USF”) that uses a cannabinoid as one of the active ingredients.

We have exclusive rights to the patent filing.

IGC-AD1, an oral tincture, is also modelled around the patent filing by USF.

On May 14, 2021, the Company announced it had completed Cohort 1 of three anticipated cohorts in its Phase 1 trial.

This was followed by Company announcement for completion of Cohort 2 on June 7, 2021.

IGC’s Phase 1 study is a placebo-controlled Multiple Ascending Dose (“MAD”) study on individuals suffering from Alzheimer’s disease.

This study is also evaluating the pharmacokinetics and genotyping of CYP2C9 polymorphisms to determine impact on THC metabolism.

For example, the study includes evaluating whether individuals with a particular polymorphism of the CYP2C9 gene impacts the metabolism of THC, as compared to other individuals.

The Company hopes that this data on pharmacogenetics can eventually inform IGC on effective dosing for patients with a specific CYP2C9 polymorphism, and better predict outcomes such as the impact of its THC-based investigational new drug IGC-AD1 or its interactions with other medications.

For Cohort 1, we administered one dose of IGC-AD1 per day.

We increased the dosage to two doses of IGC-AD1 per day in Cohort 2.

In Cohort 3, we plan to escalate to three doses per day.

Alzheimer’s participants are monitored daily for safety, and for certain behavioral changes using, among others, the Neuropsychiatric Inventory (“NPI”) scale.

As part of the clinical trial process, an independent Data and Safety Monitoring Committee (“DSMC”) monitors patient safety data and other factors.

A DSMC consists of industry experts with no affiliation to the trial sponsor, which in this case is IGC Pharma, LLC, a subsidiary of IGC.

The DSMC typically recommends that a trial continue or terminate based on the committee’s evaluation of trial safety data.

The DSMC for IGC’s trial, having reviewed Cohort 1 and Cohort 2 data on Alzheimer’s participants, has recommended progressing to Cohort 3.

The Phase 1 trial is currently anticipated to conclude during the second quarter of the Fiscal 2022.

Products & Services

Infrastructure s egment

We have been operating the Infrastructure segment since 2008 and our revenue in Fiscal 2020 was primarily derived from this segment:

a) Execution of Construction Contracts – The Company is executing a road building contract in Kerala, India valued initially at approximately $0.6 million.

Throughout Fiscal 2020, the Company worked on execution of the contract as well as sought approval for an expansion of the contract.

The total value of the contract was increased to approximately $1.1 million.

The Company estimates that it will take between 12 and 15 months to complete the work.

Work on this project has been temporarily suspended due to COVID-19.

We expect to re-start the project in the second quarter of Fiscal 2021.

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.

This work has been adversely affected due to COVID-19.

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.

This business is seasonal and had minimal revenue during Fiscal 2020.

Life Science s segment

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.

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.

We are enthusiastic about the potential of these concepts to address various segments of the growing cannabinoid wellness and lifestyle product market.

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.

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.

The Company’s hand sanitizer products are available under the brands:

Hyalolex™ and Camas Naturals™.

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.

Hyalolex™ Drops of Clarity™, which remains our flagship product, is not an FDA-approved pharmaceutical drug.

It is currently sold in Puerto Rico through dispensaries.

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.

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.

Life Sciences segment

This segment is a) dedicated to research on cannabinoids and their safety and efficacy on diseases and ailments, and b) the creation, marketing, and sales of wellness and lifestyle brands.

CBD mentioned in the context of products, refers to hemp extracts naturally rich in cannabinoids like CBD, but with THC 0.3% or less by dry weight.

In Fiscal 2021, we advanced the development and launch of several brands among our “house of brands” in accordance with applicable laws and regulations.

We are enthusiastic about what we believe to be the potential of these concepts to address various segments of the growing cannabinoid based wellness and lifestyle product market.

In Fiscal 2021, the Company generated $723 thousand of revenue from its Life Sciences segment, primarily from the sale of hand sanitizers under various Company brands.

However, COVID-19 has forced the Company to delay and limit the launch of some of the brands and products.

The original formulation of Hyalolex™ Drops of Clarity™ is based on work that was done at USF.

USF filed a patent that we acquired and continued to pursue by responding to queries by the USPTO in Fiscal 2021.

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.

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.

The research and cell data indicated a reduction in the aggregation of amyloid protein (“Aβ protein”) that deposits as plaque between neurons, leading to interference with intra-neuronal signaling (NCBI, 2010).

The research also showed a reduction in Neurofibrillary Tangles (“NFTs”) by reducing the hyperphosphorylation of microtubule-associated protein Tau that leads to neuronal death.

Plaques and NFTs are the hallmarks of Alzheimer’s.

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.

Patients with Alzheimer’s disease may suffer from a variety of BPSD including anxiety, agitation, dementia, depression, and sleep disorder, among others.

These symptoms often result in hard-to-manage patients and caregiver distress.

Application of our formulation in animal studies using transgenic Alzheimer’s mice (mice with Alzheimer’s) showed an improvement in memory.

These exciting results led our team to create Hyalolex™ Drops of Clarity™ as an oral formulation.

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.

The trial will study the efficacy of the formulation on BPSD in patients suffering from Alzheimer’s.

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.

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.

Our facility in Vancouver is registered with the FDA as are most of our hand sanitizer formulations.

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.

In Fiscal 2020, we reported no revenue from hand sanitizers, as they went on sale in April 2020.

Hyalolex TM brand hand sanitizers are currently available for purchase online at www.hyalolexhandsanitizer.com .

In Fiscal 2020, we prepared our production facility to offer extraction, distillation, tolling, and white labeling services under the brand of Holi Hemp™.

These results led our team to create Hyalolex™ Drops of Clarity™ as an oral formulation.

The product was test marketed in Puerto Rico.

A version of this formulation (IGC-AD1) is currently filed as an INDA with the FDA, for which we are conducting a phase 1 trial.

We do not presently expect to market Hyalolex Drops of Clarity widely while the Company is pursuing its INDA.

In Fiscal 2021, we prepared our production facility to offer trading, distillation, tolling, and white labeling services under the brand of Holi Hemp™.

However, due to COVID-19, we were unable to complete the commissioning of all the equipment.

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.

We expect that the facility will also allow us to offer services such as extraction and distillation of biomass to hemp farmers.

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2813509/

Update on previously announced products

Natrinol™, previously named as a product for Pain, has been folded into the Holief™ brand.

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.

NO3A™, initially targeting the beverage industry, has been folded into Sunday Seltzer™.

We expect that when the equipment is commissioned, COVID-19 permitting, we will be vertically integrated in the hemp industry, where we can control the processing and production of products as well as offer services such as distillation of extracted hemp crude.

In Fiscal 2021 we completed the branding and development of Holief.

“Holief” is derived from the words holistic and relief.

The brand is made up of hemp-based CBD infused products including our patented formulation for treating pain and other products that use a combination of an analgesic and CBD, to help provide a natural, alternative to pain medications, such as opioids.

Under this brand, we have in particular, created several products for women.

These include a menthol (analgesic) and CBD cream designed to help alleviate period cramps.

In addition, we created a tincture containing CBD, primrose oil, and peppermint oil to help with Post Menstrual Symptoms.

We expect to market these products online and through retail outlets in accordance with applicable law and regulation.

In Fiscal 2021 the Company completed the branding and development of Herbo, a premium hemp-based CBD infused organic topical and spa line of products.

The products all carry a signature fragrance derived from sandalwood oil, rose, lavender, cypress, and hemp.

The products are topicals such as our CBD infused body lotion, body butter, body oil and menthol body balm.

We expect to market these products online and through retail outlets in accordance with applicable law and regulation.

Sunday Seltzer ™

In Fiscal 2021 the Company completed the branding and development of Sunday Seltzer, a premium hemp-based CBD infused seltzer.

Sunday Seltzer is available in several flavors including grapefruit, lemon, blackberry, cucumber, ginger, and passion fruit.

Our initial launch of the product is in retail stores in New Jersey, New York, and Connecticut.

The products are all low- or no-calorie beverage options.

Infrastructure segment

We have been operating the infrastructure business since 2008.

Our revenue in Fiscal 2020 was primarily derived from this segment and included:

a) Execution of Construction Contracts – The Company is executing a road building contract in Kerala, India valued at approximately $1.2 million.

Work on this project is sporadic based on COVID-19 restrictions.

This work has been adversely affected by the COVID-19 pandemic.

There was no revenue from this business line during Fiscal 2021.

c) Rental of Heavy Construction Equipment – We own heavy construction equipment such as motor grader and rollers, that we rent to construction contractors.

This business is seasonal and had minimal revenue during Fiscal 2021.

Business Strategy

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.

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.

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:

1) sale of branded products, under the Herbo™, Hyalolex™, Camas Naturals™, Holief™ and Sunday Seltzer ™ product lines, among others;

2) white labeling of products such as lotions, creams, oils, for other brands;

3) wholesale of hemp extracts including hemp crude extract and hemp isolate, among others;

We have a two-pronged strategy for our Life Sciences, biopharmaceutical component:

the initial prong is to investigate IGC-AD1 for efficacy in managing the symptoms of Alzheimer’s disease.

This involves conducting Phase 1 through Phase 3 trials on IGC-AD1 over the next several years, with the anticipated goal of demonstrating efficacy and potentially obtaining FDA approval for IGC-AD1 as a cannabinoid-based formulation that can help manage some symptoms for patients suffering from Alzheimer’s disease.

The second prong is to investigate the potential efficacy of IGC-AD1 on memory and/or decreasing or managing plaques and tangles, some of the hallmarks of Alzheimer’s disease.

Our pipeline of investigational cannabinoid formulations includes pain creams and tinctures for pain relief.

We believe that the biopharmaceutical component of our Life Sciences strategy will take several years and involves considerable risk;

however, we believe it may involve greater defensible growth potential and first-to-market advantage.

We believe that additional 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, are likely to be critical to the development and delivery of innovative products and positive patient and customer experiences.

Part of our strategy is to leverage our R&D and our intellectual property, to develop products that we believe are likely to be well differentiated and supported by science through planned pre-clinical and clinical trials.

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, may offer positive results for the management of certain conditions, symptoms, and side effects.

Our shorter-term strategy also includes becoming vertically integrated in the hemp industry, as we believe this may afford us the opportunity to create the right processes, quality, and replicability for eventually creating pharmaceutical grade formulations.

We also believe this may provide us with several profit opportunities, all conducted in accordance with applicable laws and regulations, and only in locations where it is legal to do so, such as:

sale of our products, under the Herbo™, Hyalolex™, Holief™, and Sunday Seltzer™ brand lines, among others;

white labeling of products such as hemp-based CBD infused lotions, creams, and oils for other brands;

wholesale of hemp extracts including hemp crude extract and hemp isolate;

processing of hemp biomass and crude oil for farmers in the Northwest U.S.

5) sale of hand sanitizers.

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.

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.

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.

Our approach is to look at the efficacy for BPSD first, and, if successful turn our attention to the hallmarks of Alzheimer’s:

plaques and tangles.

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.

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.

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.

Fiscal 2020 Highlights

• The Company is executing a road building contract in Kerala, India valued initially at approximately $0.6 million.

Throughout Fiscal 2020, the Company worked on execution of the contract as well as sought approval for an expansion of the contract.

The total value of the contract was increased to approximately $1.1 million.

The Company estimates that it will take between 12 and 15 months to complete the work.

Work on this project has been temporarily suspended due to COVID-19.

We expect to re-start the project in second quarter of Fiscal 2021.

• 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.

• IGC filed a provisional patent, IGC 510, Compositions and Methods using CBD for treating stammering and symptoms of Tourette syndrome with the USPTO.

• The Company established an approximately $0.5 million facility in San Juan, Puerto Rico to house and conduct trials.

• As part of an out-reach and marketing campaign, we distributed samples of Hyalolex™ Drops of Clarity™, to dispensaries in Puerto Rico.

The formulation is currently available in about 51 dispensaries in Puerto Rico.

While this is a small market penetration, it allows us to collect data.

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.

These will all be branded under Hyalolex™, with the original formulation branded as Hyalolex™ Drops of Clarity™.

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.

• 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.

• The Company advanced its branding and product strategy with the development of several brands aimed at various sectors of the market.

The progress includes filing trademark applications and intent to use applications;

securing URLs;

creating product formulations, labelling, and packaging;

obtaining product insurance;

securing product development teams;

conducting focus groups;

performing quality and taste testing;

and organizing and registering limited liability companies to mitigate risk, among others.

• The Company grows hemp in Arizona.

The crop has passed inspection by the Arizona Department of Agriculture (“AZDA”) and has been certified as legal by AZDA.

However, the harvest is delayed due to of the difficulty in finding workers because of the social distancing rules brought on by COVID-19.

• We prepared our facilities in Washington for the dual purpose of manufacturing finished products as well as for extraction and distillation.

Most of our hemp processing and distillation equipment is sourced from China.

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.

• On February 15, 2020, the Company signed a Share Subscription Agreement (“SSA”) with Evolve I, to acquire 20% of Evolve I.

As of March 31, 2020, the Company has not completed its due diligence.

• 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.

IGC filed this application for its IGC-504 formulation (#15/751,901) on August 11, 2016.

using our manufacturing and trading platform for trading in infrastructure commodities to assist in delivering emergency products such as hand sanitizers, gloves, and other personal protection equipment for the length of the COVID-19 pandemic.

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, as well as personal protection equipment.

We are currently experiencing a lack of certainty in this business segment due to the COVID-19 pandemic and stay-at-home and shelter in place orders, especially in India and Hong Kong.

Markets and Distribution

Life Sciences segment

Our brands are designed to address different demographics and segments of the market.

For example, Sunday Seltzer™ addresses the infused seltzer market.

Herbo™ addresses the spa and wellness market.

Holief™ addresses the pain market, including the menstrual cramp market.

We plan on marketing these brands to the U.S.

Latino market as this is among the fastest-growing segment in the U.S.

GDP that in 2018 was around $2.6 Trillion.

(Forbes, 2020).

It is projected that the Hispanic population will reach 111.22 million by 2060 from 59 million in 2018 (Statista, 2021).

In Fiscal 2021, we have two customers and three suppliers of raw materials, which accounts for over 10% of sales and cost of sales.

The COVID-19 pandemic has and might continue to affect our operations which could be reflected in reduced revenue and increased costs in our Life Sciences segment in Fiscal 2022.

Revenue from our Life Sciences is less than 1% based on global revenue of relevant markets.

Overall, U.S.

sales of cannabis and hemp-derived CBD products are expected to increase in all channels—dispensary, general retail and pharmaceutical, to $20.5 billion by 2025, a compound annual growth rate (“CAGR”) of more than 40% (BDSA, 2020).

The global CBD skin care market size is anticipated to reach $3.48 billion by 2026, with a CAGR of 24.80% during the forecast period (Allied Market Research, n.d.).

Overall revenue in the Skin Care segment amounts to about $18 billion in the U.S.

The market is expected to grow annually by approximately 5.01% (CAGR 2021-2025) (Statista, n.d.).

The market is primarily driven by growing awareness with respect to the perceived benefits of CBD infused personal care products.

Cannabis infused drink market is also expected to reach $1.4 billion by 2023 (Statista, 2020).

Revenue from hand sanitizer amounted to $360.58 million in U.S.

The market is expected to grow annually by 8.47% (CAGR 2021-2025) (Statista, 2021).

Infrastructure segment

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We also purchase and resell physical commodities that are used in the construction business by constructions companies.

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.

In addition, we maintain a small fleet of heavy construction equipment in Kerala consisting of motor grader, rollers, etc., that is leased out to construction companies.

In Fiscal 2021, we have a total of 1 customer and 1 subcontractor/suppliers of infrastructure materials, which account for over 10% of sales and cost of sales.

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.

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.

The total revenue from our infrastructure business is less than 1% of the global revenue of the rental, construction, and infrastructure commodities markets.

Life Science s segment s

Our brands are designed to address different demographics and segments of the market.

For example, Sunday Seltzer™ addresses the infused seltzer market.

Herbo™ addresses the spa and wellness market.

Holief™ addresses the pain market.

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.

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.

In Fiscal 2020, we have one supplier of raw materials and no customers, which accounts for over 10% of sales and cost of sales.

In Fiscal 2020, our suppliers are companies based in the U.S.

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.

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.

Revenue from our Life Sciences is less than 1% based on revenue of global markets.

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%.

When combined with THC products, the CBD market is expected to create a total market of $45 billion for cannabinoids by 2024 2 .

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 .

Overall revenue in the Skin Care segment amounts to about $18 billion in the U.S.

The market is expected to grow annually by 3.5% (CAGR 2020-2023).

The market is primarily driven by growing awareness with respect to the benefits of CBD infused personal care products.

Cannabis infused drink market is also expected to reach $1.4 billion by 2024.

Further, it is estimated that 535,000 acres of land was licensed for hemp production in the U.S.

in 2019, leading to an estimate of between 96 and 120 million pounds of CBD rich hemp biomass suitable for extraction.

Business Seasonality

The Company has historically experienced seasonality in the Infrastructure segment based on low work in construction during the monsoon season.

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.

2 https://bdsa.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024/

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

4 https://www.statista.com/outlook/70020000/109/skin-care/united-states

5 https://www.cannabisbusinesstimes.com/article/us-cannabis-drinks-market-2024/

Wholesale Hemp Price Benchmarks

Research and Development

Our success is based on our ability to innovate and bring unique products to market that address specific needs.

We spent about $1 million and $1.3 million in Fiscal 2020 and Fiscal 2019, respectively.

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.

We expect to spend resources on R&D as we conduct research on the benefits of various cannabinoids.

Moreover, as most of the hemp harvest in America occurs in the fall, there tends to be pricing pressure based on the volume of hemp biomass being harvested.

Some of the markets for the Company’s products and services are highly competitive, and some are not, as described below:

Infrastructure segment:

This business is currently limited to India and Hong Kong.

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.

Life Sciences segment:

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.

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.

We believe our differentiation from our competitors, for example, in the use of phytocannabinoids for the management of symptoms related to Alzheimer’s, is based primarily on our data, patent filings, and experienced team, offering us an early-mover advantage.

We face competition from well-funded seasoned companies.

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.

On the wellness and lifestyle 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 labeling and tolling.

On the product side we face competition from companies in the food, beverage, and skin care industries.

It is unclear how the FDA guidance and ruling on CBD-infused food products, when it is released, will impact the market.

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.

It is unclear how the FDA guidance and ruling on hemp-based CBD infused food products, when it is released, will impact the market.

Infrastructure segment:

This business is currently limited to India and Hong Kong.

Despite the passage of the 2018 Farm Bill, the FDA has not set out guidance or rules on the infusion of hemp-based CBD into food and beverage products.

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.

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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;

a network of doctors, scientists with Ph.D.

degrees and intellectual property legal experts that have a sophisticated understanding of drug discovery, research, FDA filings, intellectual protection, and product formulation;

knowledge of various cannabinoid strains, their phytocannabinoid profile, extraction methodology and impact on various pathways;

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knowledge of research and development in the field;

• patent IGC-501 and IGC-504 for treatment of pain and treatment of cachexia and eating disorders in humans and veterinary animals, respectively;

• a team with experience in manufacturing, marketing, and selling cannabinoid products.

patents IGC-501, IGC-504 and IGC-502 for treatment of pain, treatment of cachexia and eating disorders in humans and veterinary animals, and treatment of seizures in humans and veterinary animals, respectively;

facilities and a team with experience in manufacturing, marketing, and selling products.

Licenses, Technology and Cybersecurity

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General business

License to grow and transport hemp.

Industrial Alcohol User Permit

License to grow hemp

Industrial Alcohol User

Clinical Trials

Good Manufacturing Practices (GMP) certification

General business licenses

License to grow and transport hemp.

License to grow hemp

Industrial Alcohol User Permit

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Business registrations with tax authorities in various states in India

Life Sciences products and General Management

General business license

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits

Fondo Nacional De Estupefacientes (FNE) Permits

General business license

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Permits

Fondo Nacional De Estupefacientes (FNE) Permits

Purchase and Resale of physical commodities

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Hemp and Marijuana are both cannabis plants.

Under the 2018 Farm Bill, Hemp is classified as a cannabis plant that has THC below 0.3% by dry weight.

Under the 2018 Farm Bill, Hemp is classified as a cannabis plant that has THC 0.3% or less by dry weight.

Marijuana is classified as a cannabis plant that has THC above 0.3% by dry weight.

Marijuana remains illegal under federal law, including in those states in which the use of marijuana has been legalized for medical and or recreational use.

On the other hand, on December 12, 2018, the Senate and the House approved the 2018 Farm Bill that the President signed into law.

It contains provisions that make industrial hemp legal.

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.

On the other hand, the 2018 Farm Bill, which was effective January 1, 2019 contains provisions that make industrial hemp legal.

Although, 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.

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 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.

For example, in the state of Arizona, where we grew hemp, we were required to apply for licenses and register with the state the geo-location of all our operations, including the land on which hemp was grown and the facilitates where hemp will be processed.

These regulations are evolving, differ from jurisdiction to jurisdiction, and are subject to change.

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The NDA must include the results of all pre-clinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.

The cost of preparing and submitting an NDA is substantial.

Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee, for Fiscal 2020 $2,942,965, and the manufacturer and/or sponsor under an approved NDA are also subject to annual program fees, for Fiscal 2020 $325,424.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review.

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An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks.

REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use, or ETASU.

As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, (“REMS”), to help ensure that the benefits of the drug outweigh the potential risks.

REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use, (“ETASU”).

ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries.

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Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application, or ANDA.

Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application, (“ANDA”).

An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown through bioequivalence testing to be bioequivalent to the listed drug.

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Special Protocol Assessment

A company may reach an agreement with the FDA under the Special Protocol Assessment, or SPA, process as to the required design and size of clinical trials intended to form the primary basis of an efficacy claim.

A company may reach an agreement with the FDA under the Special Protocol Assessment, (“SPA”), process as to the required design and size of clinical trials intended to form the primary basis of an efficacy claim.

According to its performance goals, the FDA is supposed to evaluate the protocol within 45 days of the request to assess whether the proposed trial is adequate, and that evaluation may result in discussions and a request for additional information.

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Under the FDC Act and FDA guidance implementing the statutory requirement, an SPA is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, public health concerns emerge that were unrecognized at the time of the protocol assessment, the sponsor and the FDA agree to the change in writing, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of our lead product candidate, such as IGC-AD1 or any other for which we may seek regulatory approval.

Sales in the U.S.

will depend in part on the availability of adequate financial coverage and reimbursement from third-party payors, which include government health programs such as Medicare, Medicaid, TRICARE, and the Veterans Administration, as well as managed care organizations and private health insurers.

Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction, or denial by payors.

The process for determining whether a payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product.

Third-party payors may limit coverage to specific products on an approved list or formulary, which might not include all the FDA-approved products for a particular indication.

Also, third-party payors may refuse to include a branded drug on their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or another alternative is available.

Medicare Part D, Medicare’s outpatient prescription drug benefit, contains protections to ensure coverage and reimbursement for oral oncology products, and all Part D prescription drug plans are required to cover substantially all oral anti-cancer agents.

However, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be available.

Private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations.

Sales of products such as IGC-AD1 or any other product candidates will therefore depend substantially on the extent to which the costs of our products will be paid by third-party payors.

Achieving favorable coverage and reimbursement from the Centers for Medicare and Medicaid Services (“CMS”) and/or the Medicare Administrative Contractors is typically a significant gating issue for successful introduction of a new product.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.

In order to obtain coverage and reimbursement for any product that might be approved for marketing, we may need to conduct studies in order to demonstrate the medical necessity and cost-effectiveness of any products, which would be in addition to the costs expended to obtain regulatory approvals.

Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development.

Employees and Consultants

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Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only.

IGC maintains several Internet addresses including www.igcinc.us, www.holihemp.com , www.hyalolex.com and www.herbo.com , among others.

IGC maintains several internet addresses including www.igcinc.us, www.igcpharma.com , www.holihemp.com , www.hyalolex.com and www.herbo.com , among others.

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.

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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.

What changed 10-K

Item 1. Business