What changed in this filing

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Item 1. Business

2022-06-23 compared with 2021-06-14 · 322 added, 226 removed, 224 unchanged (71% of the section changed)

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.

Corporate History

IGC has two business segments:

Infrastructure and Life Sciences.

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.

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.

Infrastructure Segment

The India based infrastructure segment involves the execution of construction contracts.

Life Sciences Segment

Biopharmaceutical :

Since 2014, this part of our business has focused primarily on the potential uses of phytocannabinoids, including Tetrahydrocannabinol (“THC”) and Cannabidiol (“CBD”), in combination with other compounds to treat multiple diseases, including Alzheimer’s.

As a company engaged in the clinical-stage biopharmaceutical industry, we focus our research and development efforts, subject to results of future clinical trials, on seeking pharmaceutical solutions that may a) alleviate neuropsychiatric symptoms such as agitation, anxiety, and depression associated with dementia in Alzheimer’s disease;

and b) halt the onset, progression, or cure Alzheimer’s disease.

We currently have one investigational new drug candidate, “IGC-AD1”, in a Phase 2 clinical trial for agitation in dementia from Alzheimer’s.

IGC-AD1 is a cannabis-based compound, which is made up of ultra-low doses of THC along with another compound as active ingredients.

The second molecule, TGR-63, is an enzyme inhibitor that has been shown, in pre-clinical trials, to reduce neurotoxicity in Alzheimer’s cell lines.

Neurotoxicity causes cell dysfunction and death in Alzheimer’s disease.

If shown to be efficacious in halting this process, this inhibitor has the potential to treat Alzheimer’s disease by ameliorating Aβ plaques.

Over the Counter Products :

We have created a cannabinoid-based women’s wellness brand, Holief™ available through online channels and a CBD-caffeine-infused energy drink, Sunday Seltzer™, available through wholesale channels.

Holief™ is an all-natural, non-GMO, vegan, line of over the counter (“OTC”) products aimed at treating menstrual cramps (dysmenorrhea) and premenstrual symptoms (“PMS”).

Sunday Seltzer™ is an all-natural, organic, carbonated energy drink with natural caffeine from green tea extract, CBD, vitamins B, vitamin C, no added sugars, and no preservatives.

The energy drink is available in two flavors, pomegranate-lemon, and peach-ginger.

In addition, Sunday Seltzer™ is also available in four flavors with CBD, vitamins B, vitamin C, and no caffeine.

Both Holief™ and Sunday Seltzer™ are compliant with relevant federal, state, and local laws, and regulations.

Alzheimer ’ s disease

The National Institute on Aging (“NIA”) at the National Institutes of Health (“NIH”) defines Alzheimer’s as an irreversible progressive brain disorder that destroys memory and thinking skills.

According to the Alzheimer’s Association, approximately 10% of Americans over 65 have Alzheimer’s disease and many more could be undiagnosed.

Some researchers suspect that half of the 80 and over population will develop Alzheimer’s (Piedmont Healthcare, (n.d);

Alzheimer’s Association, 2021).

Alzheimer’s is the third leading cause of death, after heart disease and cancer.

The Alzheimer’s crisis is growing and by 2030, World Health Organization (“WHO” 2020), estimates that 55 million people worldwide will have dementia.

With no approved cure the global cost of dementia is expected to rise to about $2.8 trillion by 2030.

Dementia is a broader term used to describe the loss of cognitive functioning, including thinking, remembering, reasoning, and behavioral abilities.

The WHO believes Alzheimer’s may be responsible for up to 70% of dementia.

Alzheimer’s disease, and the dementia associated with it, is a progressive disease.

Symptoms such as agitation, anxiety, depression, sleep disturbance (sundown syndrome), delusions, and hallucinations often begin to appear in patients in their mid-60s.

The NIA categorizes Alzheimer’s in three stages - mild, moderate, and severe (NIA, 2019).

Symptoms of mild Alzheimer’s can include wandering (getting lost, not remembering the way home), trouble handling money and paying bills, repeating questions, and personality or behavior changes.

As the disease progresses to moderate, there is damage to the areas of the brain that control language, reasoning, sensory processing, and conscious thought.

Patients can have difficulty with multistep tasks such as getting dressed.

Behavioral problems including hallucinations, delusions, paranoia, and impulsive behavior can also increase.

When severe Alzheimer’s sets in, plaques and tangles spread throughout the patient’s 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 of their life, they may be largely bed-ridden as the body shuts down (NIA, 2021).

Currently, there are limited options to help Alzheimer’s patients with the debilitating symptoms of the disease or relief for the burden placed on their caregivers (Cheng, 2017).

Our Phase 1 trial for IGC-AD1 may provide hope for those patients suffering from mild to severe dementia due to Alzheimer’s disease.

Alzheimer ’ s Disease (AD) Pathology

Alzheimer’s pathology can be divided into two categories, familial or inherited AD and sporadic AD.

The histopathology of early onset familial AD and late onset sporadic AD are indistinguishable.

Both forms of AD are characterized by extracellular amyloid-β (Aβ) plaques and intracellular tau-containing neurofibrillary tangles (Gӧtz, et al., 2011).

Simplistically, in normal brain functioning a large protein called Amyloid Precursor Protein (APP) is cleaved into smaller fragments called Aβ proteins.

In a normal brain these are subsequently broken down further and cleared.

However, in AD brains these Aβ proteins are not broken down and cleared;

they instead stick to one another, and deposit as inter neuronal sticky plaque—that is, they deposit as plaque between neurons.

In the brain, within a neuron tau (τ) is a key protein that holds together the transport scaffold.

As an analogy, it is the brick and mortar of the highway over which nutrients are transported within a neuron.

In an AD brain, tau breaks down due to a process called hyperphosphorylation and is unable to hold the transport highway.

The breakdown results in neurofibrillary tangles (NFTs) and eventually leads to neuronal death.

The misfolded structure of Aβ proteins, along with NFTs, generate a characteristic tendency for their aggregation (Chiti & Dobson, 2006) around damaged or dead neurons and within cerebral vasculature in the brain.

It manifests by memory loss followed by progressive dementia.

It has long been believed that Aβ1–40 (Aβ40) and Aβ1–42 (Aβ42) aggregates are the constituents of the insoluble plaques that are characteristic of AD.

This disease is also associated with neuroinflammation, excitotoxicity, and oxidative stress (Campbell & Gowran, 2007;

Rich, et al., 1995).

However, the continuous aggregation of Aβ proteins along with hyperphosphorylation of tau protein inside the cell, causing NFT formation, are generally accepted as the major etiological factors of the neuronal cell death associated with the progression of Alzheimer’s disease (Octave, 1995;

Reitz, et al., 2011;

Pillay, et al., 2004).

IGC-AD1 Studies on Alzheimer ’ s

While investigating cannabinoid-based combination therapies, researchers at the University of South Florida (“USF”) discovered the potential for cannabis to play a role in treating Alzheimer’s.

The discovery was featured on Dr.

Sanjay Gupta’s CNN show Weed 2.

This work also led to several patent filings including one that was granted by the United States Patent and Trademark Office (“USPTO”).

In the fiscal year 2018, IGC acquired exclusive rights to the research data and patent filing.

The research on the active ingredients of IGC-AD1 (IGC-AD1 Actives) showed that they, in combination, had potentially positive effects on Alzheimer’s disease.

Specifically, the pre-clinical research on the IGC-AD1 Actives showed the following:

Impact on plaque levels:

Cao et al., (2014) reported a dose-dependent decrease in Aβ40 levels in N2a/APPswe cells (AD cell lines) in the presence of the IGC-AD1 Actives, after 24 hours of incubation.

Furthermore, repeated exposure reduced Aβ40 levels without changing APP levels, a novel non-obvious and important finding as APP is a key protein associated with brain functioning.

The mode of action is attributed to its direct interaction with Aβ protein and inhibition of Aβ aggregation (Cao et al., 2014).

Impact on Tau Protein :

IGC-AD1 Actives lowered the level of phosphorylated Tau (pTau) expression in N2a/APPswe cells in a dose-dependent manner.

The mode of action was attributed to the direct interaction of IGC AD1 Actives with GSK3 protein kinase, which lowers pTau expression (Cao et al., 2014).

Impact on neurotoxicity :

Analysis on the neurotoxicity at various doses in N2a/APPswe cells after incubation for up to 24 hours showed that the Actives were non-toxic to cells at all doses (Cao et al., 2014).

Impact on Mitochondria :

In a novel and non-obvious finding it was discovered that THC in low doses has the unique property of enhancing mitochondrial functioning in isolated mitochondria obtained from N2a/AβPPswe cells (Cao et al., 2014).

This finding is contrary to what THC does at higher doses, alluding to a bi-phasic nature of THC.

Results with a mouse model:

Cao’s group extended their in vivo study to aged APP/PS1 mice to evaluate THC’s neuroprotective effects on behavioral models.

They used a radial arm water maze (RAWM) to test spatial memory.

RAWM tests revealed that treating aged APP/PS1 mice with low doses of THC for three months increased their spatial learning skills in a dose-dependent way (Wang et al., 2022).

Based on the evidence, we hypothesize that IGC-AD1 may have several AD modifying benefits, including:

Reduction in Aβ expression without a reduction in APP.

Reduction in Aβ aggregation and consequently plaques.

Enhanced mitochondrial functioning.

Reduction in the phosphorylation of tau and consequently a reduction in neurofibrillary tangles (NFTs).

Research has shown that micro-dosing of THC could increase the functioning of mitochondria on AD cell lines and potentially promote the growth of new pathways (neurogenesis) (Suliman, et al., 2017).

Micro-dosing of THC affects the brain radically differently from the normal dosing in the FDA-approved prescription drug, Dronabinol.

For example, there is a significant body of research showing that THC is neuro-toxic at normal levels, but micro-doses of THC have been shown to be non-toxic to neurons.

With the exciting results of these pre-clinical studies, the Company developed an oral formulation, IGC-AD1, and completed a Phase 1 trial on AD patients.

IGC-AD1 Clinical Trial Data

To the best of our knowledge, the Company’s Phase 1 clinical trial testing the safety and tolerability of IGC-AD1 is the first human clinical trial using low doses of THC, in combination with another molecule, to treat symptoms of dementia in Alzheimer’s patients.

THC is a naturally occurring cannabinoid produced by the cannabis plant.

It is known for being a psychoactive substance that can impact mental processes in a positive or negative way depending on the dosage.

THC is biphasic, meaning that low and high doses of the substance may affect mental and physiological processes in substantially different ways.

For example, in some patients, low doses may relieve a symptom, whereas high doses may amplify a symptom.

IGC’s trial is based on low dosing and controlled trials on patients suffering from Alzheimer’s disease.

A double blind, single-site, randomized, three cohort, multiple-ascending dose (MAD) clinical trial (FDA IND Number:

146069, NCT04749563) was conducted using the investigational new drug (IND) IGC-AD1.

IGC received approval to proceed with the Phase 1 clinical trial from the FDA on July 30, 2020.

The primary objective was safety and tolerability in elderly patients suffering from Alzheimer’s disease.

The secondary objective was measuring changes in neuropsychiatric symptoms (NPS) using the neuropsychiatric inventory (NPI) as well as to assess the risk of suicide using the Columbia-Suicide Severity Rating Scale (C-SSRS).

The exploratory objective was to measure the pharmacokinetics (PK) and the impact of polymorphisms of the gene CYP2C9 on PK.

In all three cohorts, ten participants received IGC-AD1 and two received a placebo.

There were at least four days of washout between the cohorts.

In Cohort one, Cohort two, and Cohort three the doses were q.d.

(once per day), b.i.d.

(twice per day), and t.i.d.

(three times per day), respectively.

The trial concluded that all three dosing levels were safe with no serious or life-threatening events or deaths reported.

On December 1, 2021, IGC submitted the Clinical/Statistical Report (CSR) to the FDA on its Phase 1 trial titled “A Phase I Randomized Placebo-Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 In Subjects with Dementia Due to Alzheimer’s Disease.” Data that is relevant to the Phase 1 protocol and the design of the Phase 2 trial are presented here.

The data presented here is not exhaustive.

Primary Endpoint:

Safety & Tolerability (S&T)

S&T was assessed by recording both solicited and non-solicited Adverse Events (AEs).

The solicited AEs, assessed daily, were somnolence, falls, dizziness, asthenia, suicidal ideation, hypertension, psychiatric symptoms, and paradoxical nausea.

All AEs were graded as mild, moderate, severe, life-threatening, and serious (SAE).

● In all three Cohorts, a) there were no SAEs, b) no life-threatening AEs, and c) no deaths.

● One AE, mild dizziness, reported in Cohort 1, was deemed to be related to IGC-AD1.

All other AEs across all cohorts were deemed to be not related to IGC-AD1 or to the placebo.

● In Cohort 1, in the group that received IGC-AD1 (N=10), 50% reported hypertension, 40% reported asthenia, 30% reported somnolence and dizziness, 20% reported psychiatric symptoms, and 10% reported falls.

One case of dizziness was deemed by the principal investigator (PI) to be related to IGC-AD1.

In the placebo group (N=2) 100% reported hypertension, and 50% reported somnolence and falls.

● In Cohort 2 for the IGC-AD1 group, 60% reported psychiatric symptoms, 50% reported somnolence and asthenia, 30% reported hypertension, 20% reported nausea and dizziness, and 10% reported falls and suicidal ideation.

In the placebo group 100% reported somnolence, 50% reported dizziness and hypertension.

● In Cohort 3 for the IGC-AD1 group, 70% reported somnolence, 60% reported psychiatric symptoms, 50% reported dizziness and asthenia, and 30% reported hypertension.

In the placebo group 100% reported somnolence, and 50% reported hypertension and psychiatric symptoms.

Secondary Endpoints:

Neuropsychiatric Inventory (NPI)

Neuropsychiatric Symptoms (NPS) such as delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorders, and appetite/eating disorders are prevalent in patients who have Alzheimer’s disease (Phan et al., 2019).

NPS in Alzheimer’s is a significant burden on patients and caregivers, and at some point, in the progression of Alzheimer’s disease, more than 97% of patients suffer from at least one symptom.

The Neuropsychiatric Inventory (NPI) (Cummings et al., 1994) measures the severity of each symptom and establishes both individual symptom scores as well as an overall NPI score.

Separately, the NPI also scores caregiver distress (NPI-D).

The NPI is used by about 50% of neurologists to assess and treat Alzheimer’s patients (Fernandez et al., 2010).

In the Phase 1 trial conducted on patients with Alzheimer’s disease, we measured changes in NPS as assessed by the NPI-12 as well as caregiver distress as assessed by the NPI-D.

In the Phase 1 trial (N=10), seven received the active medication and at baseline they had symptomatic Agitation with domain scores between two and twelve.

In Cohorts two and three six Participants had symptomatic Agitation.

We measured and analyzed the change in the mean NPI score for Agitation between Day 1 and Day 10 and between Day 1 and Day 15 for all three cohorts.

As shown in Table below, our analysis shows Cohort 2 had the largest absolute change in the mean Agitation score between Day one and Day ten (53% drop, p=.085) as well as between Day 1 and Day 15 (67% drop, p=.05).

NPI analysis for each of the three cohorts

Cohort 1 (n=7)

Cohort 2 (n=6)

Cohort 3 (n=5)

P(T<=t) two-tail

According to the NPI Test, a reduction of 4 points or 30% in the score is considered clinically meaningful.

In addition, we also used a paired 2-tailed t-test with 9 degrees of freedom to assess the statistical significance of the decrease both in the overall NPI and individual NPI domains.

● In Cohort 1 for those on IGC-AD1, the mean NPI decreased from a baseline 31.5 (SD 27.2) to 16.7 (SD 16.2) on day 10 ( p = 0.0044) and 14.8 (SD 16.0) on day 15 ( p = 0.0095).

o Individual domains that showed improvement were in Agitation ( p = .05), Dilutions ( p = .05), Anxiety ( p = .09), and Appetite and Eating Disorders ( p = .01).

● In Cohort 2 for those on IGC-AD1, the mean NPI decreased from a baseline of 22.2 (SD 14.8) to 10.4 (SD 11.5) on day 10 ( p = 0.0026) and 12.4 (SD14.7) on day 15 ( p = 0.0127).

o Individual domains that showed improvement were Agitation ( p = .06), Irritability ( p = .04), and Depression ( p = .01).

● In Cohort 3 for those on IGC-AD1 the mean NPI decreased from a baseline of 16.0 (SD14.7) to 14.6 (SD10.9) on day 10 ( p = 0.6751) and 7.9 (SD 9.0) on day 15 ( p = 0.0113).

o Individual domains that showed improvement was Agitation ( p = .06).

Phase 2 Clinical Trial Update

The Company has initiated a protocol titled “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo- controlled, trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease”.

The protocol is powered at 146 Alzheimer’s patients with half receiving placebo and is a superiority, parallel group study.

While subject to changes, we expect to conduct the trial at four sites, two in Canada and two in the U.S.

The primary end point is agitation in dementia due to Alzheimer’s disease as rated by the Cohen-Mansfield Agitation Inventory (CMAI) over a six-week period.

The Phase 2 trial will also look at eleven exploratory objectives, including, changes in anxiety, changes in cognitive processes such as attention, orientation, language, and visual spatial skills as well as memory, changes in depression, delusions, hallucinations, euphoria/elation, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorder, appetite, quality of life, and caregiver burden.

In addition, the trial will evaluate the impact of CYP450 polymorphisms and specifically CYP2C9 on each of the NPS and assess any reductions in psychotropic drugs, among others.

Each participant will receive two doses of IGC-AD1 (b.i.d.) or two doses of placebo per day for six-weeks.

Rationale For IGC-AD1 Phase 2

The rationale for targeting agitation associated with dementia due to Alzheimer’s:

Currently, there is no approved medication for agitation associated with dementia in AD, and about 76% of AD patients suffer from agitation as rated by the CMAI (Van der Mussele, et al., 2015).

While there can be no guarantee, we expect the Phase 2 trial to take between 12 and 18 months to complete, barring a variety of unknown factors such as a resurgence of COVID and the enforcement of lockdowns and travel restrictions.

Symptoms of AD depend on the stage of the disease:

preclinical, mild, moderate, or severe.

NPS like agitation, apathy, delusions, hallucinations, and sleep impairment are common accompaniments of dementia.

Loss of functionality, including progressive difficulty in performing instrumental and basic activities of daily living are also seen with disease progression (Tang et al., 2019).

There is a spectrum of behavioral disorders that can affect patients with AD.

These include Agitation (including “sundown syndrome”), anxiety, disturbance of sleep cycle, depression, inappropriate sexual behavior, disinhibition, and irritability, among others (Lyketsos et al., 2011).

These behavioral disturbances not only affect patient’s quality of life but also cause extreme emotional distress for the caregivers.

These disturbances can become very difficult to manage, so most of the time, combinational therapy is used (Matsunaga, et al., 2015).

This can cause secondary undesirable effects, such as excessive sleepiness, which diminishes the capability of the patient to be active and alert during the day;

dizziness, which can increase the risk for falls (Allan, et al., 2005);

worsening of cognitive function, which in turn worsens functionality (Paterniti S, et al., 2002);

and even death due to cardiovascular complications (Qiu, et.

NMI Compounds

Researchers at the Jawaharlal Nehru Centre for Advanced Scientific Research (“JNCASR”), in India, conducted approximately 10 years of research and discovery work on naphthalene monoimide (“NMI”) compounds and the role of NMI compounds on neurotoxicity associated with Alzheimer’s.

In Alzheimer’s patients, neurotoxicity is linked to beta amyloid (Aβ) plaques and Neuro Fibrillary Tangles (NFT).

JNCASR’s research based on Alzheimer’s cell lines identified one lead NMI molecule, TGR-63, from a family of NMI molecules, with the potential to reduce beta amyloid (Aβ) plaques.

Further, they demonstrated that the molecule reduces cognitive decline in a transgenic mouse model of Alzheimer’s.

Their results were published in Advanced Therapeutics under the title “Naphthalene Monoimide Derivative Ameliorates Amyloid Burden and Cognitive Decline in a Transgenic Mouse Model of Alzheimer’s Disease” on January 28, 2021.

On November 11, 2021, Hamsa Biopharma India Pvt.

(“Hamsa Biopharma”), a directly owned subsidiary of the Company, executed a Term Sheet with JNCASR, and on March 28, 2022, entered into an agreement for exclusive global rights corresponding to the molecules, technology, patent, and patent filings.

The completion of outstanding items in the agreement occurred on May 10, 2022, and the agreement with JNCASR was filed on Form 8K on May 12, 2022.

Pursuant to the agreement, IGC (through Hamsa Biopharma) acquired exclusive global rights to the molecule, which it intends to pursue as a drug development candidate, subject to further study, research, and development.

Rationale for the Acquisition of TGR-63

As described above, IGC is currently engaged in human trials with IGC-AD1 that targets certain symptoms associated with dementia in Alzheimer’s.

IGC-AD1 is currently being tested as a symptom modifying agent.

Subject to further study, research, and development, TGR-63, on the other hand, could give the Company a potential disease modifying agent to expand the Company’s pursuit of a drug that can potentially treat or modify Alzheimer’s.

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.

and select other countries.

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

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 USPTO.

Our goal is to use our intellectual property (“IP”) to develop products that we can bring to market in one or more of the following channels:

Pharmaceutical products that are subject to FDA-approvals.

We currently have one Alzheimer’s symptom modifying investigational drug candidate (IGC-AD1) in Phase 2 clinical trials under an INDA filed with the FDA, and a potential Alzheimer’s disease modifying drug development candidate (TGR-63) in a pre-clinical stage.

Branded wellness and lifestyle products to be sold in multiple retail and online channels, subject to applicable federal, state, and local laws and regulations.

Partnerships and licensing agreements with third parties who can accelerate bringing our IP to market.

The Company holds all rights to the patents that it filed with the USPTO.

In Fiscal 2017, the Company also acquired exclusive rights to the data and the patent filing from USF.

Subsequent to Fiscal 2022, the Company acquired exclusive rights to the data and the patent filing from JNCASR.

The Company believes the registration of patents is an important part of its business strategy and future success.

However, the Company cannot guarantee that these patent filings will lead to a successful registration with the USPTO.

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

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(#10,596,159 B2)

Patent issued on 06/07/2022

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Eating Disorders

Alzheimer’s Disease

Patent licensed exclusively by IGC

Patent issued on 07/20/2021

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CNS Disorders

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CBD & Method for Treating Pain (2nd)

Anticipated in Fiscal 2022

Stress relief & calm restoring beverage

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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.

Anticipated in Fiscal 2023

IGC 514 (JNCASR)

NMI compounds

Patent licensed exclusively by IGC

Granted on January 5, 2016

IGC 515 (JNCASR)

NMI Alzheimer’s

Anticipated in Fiscal 2023

COVID-19 Update

The infrastructure business, based in India and Hong Kong, had significantly lower revenue in Fiscal Year 2022 due to the continued impact of the COVID-19 pandemic and restrictions imposed by governmental entities.

We have limited visibility into when economic conditions will recover in India and Hong Kong.

Specifically:

We incurred increased expenses on a $1.2 million road-building contract in India due to COVID-19 restrictions.

We manufactured, distributed, and donated alcohol-based hand sanitizers to help communities hit hard by the COVID-19 pandemic.

We incurred the expense to provide 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.

Pandemic restrictions made it impossible to transport and process our harvested hemp crop in Arizona on a timely basis.

This resulted in a $1.7 million adjustment to our inventory that also impacted our SG&A.

Products & Services

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 (“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 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 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, 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.

In Fiscal 2022, we created and began marketing two brands, Holief™ and Sunday Seltzer™, in accordance with applicable laws and regulations.

Our brands generated $287,000 in revenue.

Although there can be no assurance, we believe these brand concepts have significant potential in the growing cannabinoid-based wellness and lifestyle market.

However, COVID-19 did force the Company to delay and limit the marketing of our brands that include Holief™ and Sunday Seltzer™:

In Fiscal 2022 we completed the development and branding of Holief™.

The word “Holief” was created by combining the words “holistic” and “relief.” The brand includes multiple, hemp-based CBD-infused products for women.

Holief™ includes a patented formulation with menthol and CBD, for treating the pain and symptoms of Premenstrual Syndrome (PMS) and period cramps.

These products provide an all-natural alternative to opioids and other pain medications.

The Holief™ product line includes creams, gummies, and herbal extracts.

Additional plant-based ingredients that have been shown to relieve PMS symptoms such as primrose oil and peppermint oil are included in many Holief™ formulations.

Holief™ is developing a cloud-based platform to connect the 31.3 million women (Statista, 2021) that suffer dysmenorrhea and PMS with health care professionals who can help.

The products are available online and through Amazon and other online channels.

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.

In Fiscal 2022 the Company completed the development and branding of Sunday Seltzer™, a premium hemp-based CBD infused seltzer.

Sunday Seltzer™ is an all-natural, organic, carbonated energy drink with natural caffeine from green tea extract, CBD, vitamins B, vitamin C, no added sugars, and no preservatives.

The energy drink is available in two flavors, pomegranate-lemon, and peach-ginger.

In addition, Sunday Seltzer™ is available in four flavors with no caffeine.

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.

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 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.

The Company’s infrastructure business has been operating since 2008, it includes:

(i) Execution of Construction Contracts – The Company is executing a $1.2 million road-building contract in Kerala, India and was recently awarded another road reconstruction project for $289 thousand;

and (ii) Rental of Heavy Construction Equipment – We rent equipment, such as a motor grader and rollers, to construction contractors.

There was minimal revenue from rentals in Fiscal 2022 due to seasonality and COVID-19 pandemic disruptions.

Business Strategy

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.

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.

The Life Sciences business strategy includes:

Subject to FDA approval, developing IGC-AD1 as a drug for treating agitation in dementia due to Alzheimer’s and investigating and developing TGR-63 for the potential treatment of Alzheimer’s disease.

Marketing Holief™, Sunday Seltzer™ and white label services.

We believe developing a drug for either symptoms or as a disease modifying agent has considerable risk due to the need for multi-year trials and FDA approval.

However, there is considerable upside and significant value creation to the extent we obtain first-to-market advantage, of which there can be no assurance.

If we were to obtain first-to-market advantage, such advantage could result in significant growth if and when an approved drug launches.

Our Holief™ strategy includes expanding the line of products and developing online services that connect women with healthcare professionals who can help with PMS and dysmenorrhea.

Building an online community that brings women together can create brand equity and loyalty.

We believe that additional investment in clinical trials, research, and development (“R&D”), facilities, marketing, advertising, and acquisition of complementary products and businesses will be critical to ongoing growth of the Life Sciences segment.

These investments will fuel the development and delivery of innovative products that drive positive patient and customer experiences.

We hope to leverage our R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through clinical trials, subject to FDA approval.

We believe this strategy can improve our existing products and lead to the creation of new hemp-based products that can provide treatment options for multiple conditions, symptoms, and side effects.

Our Infrastructure strategy includes:

competitively bidding on construction contracts, such as building roads, bridges, and other civil works in Kerala, India, and;

leasing heavy construction equipment.

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.

There is a growing awareness around the perceived benefits of CBD-infused personal care products.

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).

With diversified CBD-based brands in multiple markets, including infused seltzer (Sunday Seltzer™) and pain relief (Holief™), we are well positioned to take advantage of these market trends.

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

Approximately 31.3 million (Statista, 2021) women in America suffer from dysmenorrhea and PMS.

Our Life Sciences revenue is less than 1% of the relevant global market, which implies tremendous opportunity for growth.

We also plan to market these brands to the fast-growing U.S.

Hispanic and Latino market.

It is projected that the Hispanic and Latino population will grow from 59 million with a GDP of $2.6 trillion in 2018 to 111.22 million by 2060 (Statista, 2021).

In Fiscal 2022, our sales and suppliers were concentrated which represents some risk.

One customer accounted for over 10% of sales.

In addition, the COVID-19 pandemic could continue to affect our operations and result in lower revenue and/or higher costs in Fiscal 2023.

Infrastructure segment

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.

In Fiscal 2021, we focused on executing a construction project in the state of Kerala.

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, 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 Fiscal 2021.

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

In Fiscal 2022, our infrastructure business focused on projects in the state of Kerala.

While executing this construction project, we took advantage of other opportunities to generate revenue from our infrastructure assets.

We also lease our small fleet of heavy construction equipment, including grader, rollers etc.

to construction companies.

Our infrastructure business revenue is less than 1% of the global revenue of the rental, construction, and commodities markets.

We currently have 1 customer and 1 subcontractor/supplier of infrastructure materials.

Our ability to grow is limited by the disruption to the Hong Kong economy and the impact of COVID-19.

If and when the economy recovers, there is potential opportunity for growth given the total size of the market.

Business Seasonality

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

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:

The infrastructure segment has historically experienced seasonality with limited construction work available during the monsoon season.

The hemp business also has seasonality as most of the hemp harvest in America occurs in the fall.

Pricing pressure is based on the volume of hemp biomass being harvested.

Competition for the Company’s products and services varies by market:

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 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 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 hemp-based CBD infused food products, when it is released, will impact the market.

We are developing affordable medical products including products subject to FDA approval, which can help individuals suffering from debilitating diseases like Alzheimer’s.

While we face competition from well-funded pharmaceutical companies, our products are differentiated by the use of cannabinoids.

With our existing research, patent filings, and experienced team we have an early-mover advantage in cannabinoid-based products to treat the symptoms of Alzheimer’s.

Our wellness and lifestyle products compete with multiple well-established companies, in the food, beverage, and skincare industries.

We also face competition from companies with experience in wholesaling hemp crude extract and hemp isolate as well as companies that provide white labeling and tolling services.

It is unclear how future FDA guidance and ruling on hemp-based CBD-infused food, beverage, and cosmetic products will impact the market.

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.

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.

The infrastructure industry in India and Hong Kong is highly competitive.

Our differentiation is based primarily on price and local and industry knowledge of construction requirements in the regions where we operate.

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

This creates a complicated framework of local rules and regulations that we must navigate.

When federal rules are clearly set, we expect the demand for CBD-based food and beverages will increase.

We also believe competition will increase as major food and beverage manufacturers will enter the market.

Core business competencies and advantages

Our core competencies include the following:

Our core competencies include:

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;

degrees, and intellectual property legal experts with 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;

1 unchanged sentence

knowledge of research and development in the field;

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;

patents IGC-501, IGC-502, IGC-504, and IGC-507 for treatment of pain, treatment of seizures in humans and veterinary animals, treatment of cachexia and eating disorders in humans and veterinary animals, and Alzheimer’s Disease, respectively;

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

These competencies have enabled us to make progress on our business goals, specifically completing the Phase 1 clinical trial of IGC-AD1, which has the potential to positively impact the lives of millions of patients suffering from the symptoms of Alzheimer’s disease, subject to FDA approval.

Licenses, Technology, and Cybersecurity

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employee confidentiality and invention assignment.

Most of our data, including our accounting data, is stored in the cloud that helps us mitigate the overall risk of losing data.

Most of our data, including our accounting data, is stored in the cloud which 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.

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

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 2021:

The table below summarizes the nature of the activity, type of license required and held, and encumbrances in obtaining permits for each location where the Company operated through its subsidiaries in Fiscal 2022:

Nature of Activity

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Clinical Trials

GMP Certificate.

Infrastructure Contract, Rental of heavy equipment and land

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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 0.3% or less by dry weight.

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

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

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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 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.

3 unchanged sentences

Failure to comply with applicable U.S.

requirements may subject a company to a variety of administrative or judicial sanctions, such as imposition of clinical holds, FDA refusal to approve pending New Drug Applications (“NDA”), warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, civil penalties, and criminal prosecution.

requirements may subject a company to a variety of administrative or judicial sanctions, such as the imposition of clinical holds, FDA refusal to approve pending New Drug Applications (“NDA”), warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, civil penalties, and criminal prosecution.

Pharmaceutical product development in the U.S.

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Satisfaction of FDA premarket approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity of the product, or disease.

Pre-clinical tests include laboratory evaluation of product chemistry, and formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product.

Pre-clinical tests include laboratory evaluation of product chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product.

The conduct of the pre-clinical tests must comply with federal regulations and requirements, including the FDA’s good laboratory practices regulations and the U.S.

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Clinical trials must be conducted:

(i) in compliance with federal regulations, (ii) in compliance with Good Clinical Practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors, and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

(i) in compliance with federal regulations;

(ii) in compliance with Good Clinical Practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors;

and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Each protocol involving testing on U.S.

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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.

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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Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured.

The FDA will not approve the product unless compliance with current GMP is satisfactory, and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

The FDA will not approve the product unless compliance with the current GMP is satisfactory, and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter.

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National Institutes of Health.

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.

Information related to the product, patient population, phase of the investigation, study sites and investigator and other aspects of the clinical trial is made public as part of the registration.

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.

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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.

An ANDA provides for the 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.

Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct or submit results of pre-clinical or clinical tests to prove the safety or effectiveness of their drug product.

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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.

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

Sales in the U.S.

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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

Human Capital Management and Environment, Health, and Safety

Workplace Safety & Employee Care During COVID-19 .

Workplace safety is always a top priority for the Company.

To create and sustain a safe and healthy workplace, we have implemented initiatives designed to address risk evaluation, education and training of employees, use of appropriate personal protective equipment, and compliance with relevant health and safety standards.

As of March 31, 2022, we employed a team of approximately 52 full-time employees in our two segments.

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Such reports and other information filed by the Company with the SEC are available free of charge on the Company’s website at www.igcinc.us when such reports are available on the SEC’s website.

The public may read and copy any materials filed by the Company with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Room 1580, Washington, D.C.

The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.

The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.

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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.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.

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.

Therefore, such information should not be considered part of this report.

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.

What changed 10-K

Item 1. Business