What changed in this filing

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Item 1. Business

2023-07-07 compared with 2022-06-23 · 161 added, 129 removed, 417 unchanged (41% of the section changed)

Corporate History

IGC Pharma, Inc., formerly known as India Globalization Capital Inc., is a clinical-stage pharmaceutical company with a diversified revenue model that develops both prescription drugs and over-the-counter (OTC) products.

IGC is a Maryland corporation established in 2005 with a fiscal year that is a 52- or 53-week period that ends on March 31.

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.

Infrastructure Segment

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

Life Sciences and Infrastructure.

Our focus is on developing innovative therapies for neurological disorders such as Alzheimer’s disease, epilepsy, Tourette syndrome, and sleep disorders.

We also focus on formulations for eating disorders, chronic pain, premenstrual syndrome (PMS), and dysmenorrhea, in addition to health and wellness OTC formulations.

The Company is developing its lead candidate, IGC-AD1, an investigational oral therapy for the treatment of agitation associated with Alzheimer’s disease.

IGC-AD1 is currently in Phase 2 (Phase 2B) clinical trials after completing nearly a decade of research and realizing positive results from pre-clinical and a Phase 1 trial.

This previous research into IGC-AD1 has demonstrated efficacy in reducing plaques and tangles, which are two important hallmarks of Alzheimer’s, as well as reducing neuropsychiatric symptoms associated with dementia in Alzheimer’s disease, such as agitation.

Alzheimer’s is a progressive neurodegenerative disorder characterized by memory loss, cognitive decline, and behavioral changes.

As the most common cause of dementia, it affects over 50 million people worldwide.

The disease is associated with the accumulation of plaques and tangles in the brain, leading to brain cell deterioration and impaired cognitive functions.

Currently, there is no cure for Alzheimer’s, and the projected cost of Alzheimer’s and associated dementia is expected to be around $1 trillion just in the U.S., placing a significant financial strain on individuals, families, and the healthcare system.

The progress we are making in clinical trials gives us confidence in the potential of IGC-AD1 to be a groundbreaking therapy, with the potential to treat Alzheimer’s and also to manage devastating symptoms that separate families, increase admissions to nursing homes, and drive the cost of Alzheimer’s care.

We have filed forty-one (41) patent applications in different countries and secured nine patents, including control of four in the Alzheimer’s space.

We have built a facility for a potential Phase 3 trial and have strategic relations for the procurement of Active Pharmaceutical Ingredients (APIs).

In addition, we have acquired and initiated work on TGR-63, a pre-clinical molecule that exhibits an impressive affinity for reducing neurotoxicity in Alzheimer’s cell lines.

The advancement of IGC-AD1 into Phase 2 trials represents a significant milestone for the Company and positions us for multiple pathways to future success.

We anticipate that the positive outcomes from these and other trials will drive further growth, valuation, and market potential for IGC-AD1, although there can be no assurance thereof.

At IGC Pharma, we recognize the significance of operational excellence and cost management in clinical trials.

We have established an internal capability to manage trials, including proprietary software, rather than working with an external Contract Research Organization (CRO).

We believe this empowers us to substantially reduce the costs associated with clinical trials compared to relying on external CROs.

Our proprietary software allows us to streamline the trial processes, enabling seamless coordination and data management.

Additionally, we are integrating machine learning technologies into our software framework.

We believe this overlay of Artificial Intelligence (AI) will help us simulate trial scenarios, generate new insights to facilitate improved decision-making, efficiently design our Phase 3 trial, provide advanced data analysis, and ultimately enhancing the effectiveness and efficiency of our clinical trials, although there can be no assurance thereof.

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;

IGC develops advanced formulations for treating diseases and conditions, including Alzheimer’s disease (AD), menstrual cramps (dysmenorrhea), premenstrual syndrome (PMS), and chronic pain.

The Company’s leading drug candidate, IGC-AD1, has demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating two key hallmarks of Alzheimer’s:

plaques and tangles.

IGC-AD1 is currently in a Phase 2B safety and efficacy clinical trial for agitation in dementia from Alzheimer’s (clinicaltrials.gov, NCT05543681).

The Company also has a line of consumer product such as Holief TM , which includes gummies and pain relief creams for women experiencing PMS and menstrual cramps, all currently available for purchase.

Pharmaceutical :

Since 2014, the Company 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 pharmaceutical 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.

The Company currently has two main investigational small molecules in various stages of development:

IGC-AD1 , our lead therapeutic candidate, is a THC based formulation that has demonstrated in AD cell lines, in vitro, the potential in reducing a key peptide responsible for Aβ plaques and the potential to decrease or inhibit the phosphorylation of tau, a protein that is responsible for the formation of neurofibrillary tangles, both important hallmarks of AD.

In addition, Phase 1 human trial results demonstrated IGC-AD1’s potential to reduce agitation in dementia due to AD.

IGC-AD1 is currently in Phase 2B trials for treating agitation in dementia from AD, a condition that affects over 10-million individuals in North America and Europe, and

TGR-63 , a non-cannabinoid molecule, is an enzyme inhibitor 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.

If shown to be efficacious, in AD cell lines, 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.

We created a women’s wellness brand, Holief™ available through online channels that is compliant with relevant federal, state, and local laws and regulations.

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.

The products are available through Amazon and other online channels.

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).

According to the Alzheimer’s Association, approximately 11% of Americans over 65 have Alzheimer’s dementia, and many more could be undiagnosed.

Some researchers suspect half of the 80 and over population will develop Alzheimer’s (Alzheimer’s Association, 2023).

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

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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.

Patients can have difficulty with multi-step tasks such as getting dressed.

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

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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).

They cannot communicate, and near the end of their life, they may be largely bedridden 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).

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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.

The misfolded structure of Aβ proteins, along with NFTs, generates 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.

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Pillay, et al., 2004).

Hallmarks of Alzheimer ’ s

● Extracellular Plaque:

β-amyloid (Aβ)

● Tau Neurofibrillary Tangles (NTFs).

Causes loss of neurons & critical neuronal connections.

Also linked to Alzheimer’s:

● Metabolism disruption

● Mitochondrial dysfunction

● Neuroinflammation

IGC-AD1 Studies on Alzheimer ’ s

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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.

In 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.

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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.

Cao et al., (2014) reported a dose-dependent decrease in Aβ40 levels in N2a/AβPPswe 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.

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Impact on Tau Protein :

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

IGC-AD1 Actives lowered the level of phosphorylated Tau (pTau) expression in N2a/AβPPswe 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).

Analysis of the neurotoxicity at various doses in N2a/AβPPswe cells after incubation for up to 24 hours showed that the IGC-AD-1 Actives were non-toxic to cells at all doses (Cao et al., 2014).

Impact on Mitochondria :

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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).

Research has shown that micro-dosing of THC could increase the functioning of mitochondria on AD cell lines (Cao et al., 2014) and potentially promote the growth of new pathways (neurogenesis) (Suliman, et al., 2018).

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

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● 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).

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

Results on Neuropsychiatric Symptoms (NPS) Measured by NPI Scores

These results represent the intervention of IGC-AD1 in patients showed an overall improvement in NPS, and specifically in agitation, anxiety, and depression domains.

Caregiver distress improved as well.

Results on Agitation Measured by NPI Scores

These results represents that all three different doses, agitation improves both clinically and statistically (p<.05).

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”.

Typically, a Phase 2 trial is divided into a Phase 2A and a Phase 2B trial with the former designed to assess dosing requirements and the latter to establish efficacy.

In this document, we refer to the trial as Phase 2 and Phase 2B interchangeably.

The Company has initiated a Phase 2B 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.

While subject to changes, we expect to conduct the trial at about fifteen sites in USA, Canada, and Colombia.

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.

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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.

CYP2C9 ranks amongst the most important drug metabolizing enzymes in humans, as it breaks down over 100 drugs, including nonsteroidal anti-inflammatory all drugs.

We seek to understand how various versions of the enzyme act on IGC-AD1.

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

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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).

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.

Agitation is a behavioral syndrome characterized by increased, often undirected, motor activity, restlessness, aggressiveness, and emotional distress.

Symptoms of AD depend on the stage of the disease:

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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 include agitation, anxiety, disturbance of the sleep cycle, depression, inappropriate sexual behavior, disinhibition, and irritability, among others (Lyketsos et al., 2011).

These behavioral disturbances not only affect the 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).

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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.

Shows the reduction of the amyloid burden by TGR63 in the APP/PS1 AD phenotypic mice model:

Figure 7 shows the Reduction of amyloid burden by TGR63 in APP/PS1 AD phenotypic mice model.

A) Visualization of amyloid plaques in half hemisphere:

Confocal microscopy images of coronal section of WT, AD mice, and TGR63 treated AD mice brain immunostained with amyloid fibrils specific OC primary antibody followed by fluorescently (λ ex = 633nm, λ em = 650nm) labeled secondary antibody (red) and DAPI (blue).

B) Reduction of cortical and hippocampal amyloid burden by TGR63 treatment:

Higher magnification images of vehicle and TGR63 treated mice (WT and AD) brain sections to visualize and compare the Aβ plaques deposition in the cortex and hippocampus areas.

The brain tissue sections were immunostained with amyloid fibrils specific primary antibody (OC) and red fluorescent-labeled (λ ex = 633nm and λ em = 650nm) secondary antibody.

C, D) Quantification of Aβ plaques:

Amount of Aβ plaques (%area) deposited in different regions (cortex and hippocampus) of vehicle and TGR63 treated mice (WT and AD) brain was analyzed.

Data represent mean ± SEM, number of mice = 3 per group (* p < 0.05).

On November 11, 2021, Hamsa Biopharma India Pvt.

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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.

Contract Research Organization (CRO) and Clinical Trial Software

The IGC-Pharma Electronic Data Capture system (IGC-EDC) is a secure and user-friendly data management software designed to collect clinical trial data in electronic format.

The software incorporates rigorous security measures that help IGC to protect data and ensure compliance with regulatory requirements and industry standards.

This format is designed for our clinical trials, especially our Phase 2 trial.

The EDC system is designed to store and organize handwritten source documents, including medical history, concomitant medications, laboratory results, neuropsychiatric scales scores, adverse events, vital signs, safety calls, demographics, among others.

The system allows users to generate data reports that will be used for data analysis and generate computational models to simulate the effects of our investigational drug IGC-AD1 on participants’ outcomes.

At IGC Pharma, we recognize the significance of operational excellence and cost management in clinical trials.

One major cost driver in conducting trials is the expense associated with engaging CROs.

These costs can significantly impact on the overall budget of a trial.

To address this challenge and optimize trial costs, we have established an internal CRO, including proprietary software that we believe sets us apart from the traditional approach of outsourcing.

We believe this strategic move will enable us to reduce the costs associated with clinical trials compared to relying on external CROs, although there can be no assurance.

We have also begun working on overlaying machine learning technologies and Artificial Intelligence (AI) into the software framework for trial management with the expectation that this can lead to improved decision-making, contextual data entry, computational models, trial design (Phase 3), and data analysis, although there can be no assurance thereof.

Intellectual Property

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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.

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

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

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

The Table below provides a status of our patent filings:

Provisional Filing

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

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

Eating Disorders

Patent issued on 03/24/2020

(#10,596,159 B2)

Patent issued on 06/07/2022

(#11,351,152 B2)

The Table below provides the status of our patent filings:

GRANTED PATENTS

Alzheimer’s Disease (IGC-AD1)

Method & Composition for Treating CNS Disorders

Alzheimer’s Disease (TGR-63)

Manufactured molecule with ability to impact plaque build-up

Alzheimer’s Disease (IGC-LMP)

Composition, Synthesis, & Medical use of Hybrid Cannabinoid

Composition & Method for Treating Seizures in Mammals

Eating Disorders

Alzheimer’s Disease

Patent licensed exclusively by IGC

Patent issued on 07/20/2021

(#11,065,225)

CNS Disorders

Fatigue and energy restoration

Stammering, Tourette’s syndrome

CBD & Method for Treating Pain (2nd)

Stress relief & calm restoring beverage

Anticipated in Fiscal 2023

Alzheimer’s Disease

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.

Method & Composition for Treating Cachexia & Eating Disorders

Stuttering & Tourette Syndrome

Compositions & Methods using Cannabinoids for Treating Stuttering & Symptoms of Tourette Syndrome

Fatigue & Restoring Energy

Cannabis-Based Method & Compositions for Relieving Fatigue & Restoring Energy

Cannabinoid Composition & Method for Treating Pain

Products & Services

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.

We market our brand, Holief™, and the formulations for the products, in accordance with applicable laws and regulations.

Although there can be no assurance, we believe the brand and the formulations have significant potential in the growing natural products-based wellness and lifestyle market.

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

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

These products provide a natural alternative to pain medications such as opioids.

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

Sunday Seltzer™

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

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.

(i) Execution of Construction Contracts and (ii) Rental of Heavy Construction Equipment.

COVID-19 Update

The ongoing COVID-19 pandemic and the resulting containment measures that have been in effect from time to time in various countries and territories since early 2020 have had a number of substantial negative impacts on businesses around the world and on global, regional, and national economies, including widespread disruptions in supply chains for a wide variety of products and resulting increases in the prices of many goods and services.

Currently, our production facilities in all of our locations continue to operate as they had before the COVID-19 pandemic, with few changes other than for enhanced safety measures intended to prevent the spread of the virus.

Some of our ongoing clinical trials experienced short-term interruptions in the recruitment of patients due to the COVID-19 pandemic, as hospitals prioritized their resources towards the COVID-19 pandemic and government-imposed travel restrictions.

Some clinical trials experienced increased expenses due to new protocols to protect participants from COVID-19.

Additionally, certain suppliers had difficulties meeting their delivery commitments, and we are experiencing longer lead times for components.

Future shutdowns could have an adverse impact on our operations.

However, the extent of the impact of any future shutdown or delay is highly uncertain and difficult to predict.

It is difficult at this time to estimate the complete impact that COVID-19 could have on our business, including our customers and suppliers, as the effects will depend on future developments, which are highly uncertain and cannot be predicted.

Infections may resurge or become more widespread, including due to new variants and the limitation on our ability to travel and timely sell and distribute our products, as well as any closures or supply disruptions may be prolonged for extended periods, all of which would have a negative impact on our business, financial condition, and operating results.

Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact on our business due to the continued global economic impact of the COVID-19 pandemic.

We cannot anticipate all of the ways in which health epidemics such as COVID-19 could adversely impact our business.

See Item 1A, “Risk Factors” for further discussion of the possible impact of the COVID-19 pandemic on our business.

Business Strategy

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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.

Marketing Holief™, and formulations.

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

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

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

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

We believe that building an online community that brings women together can create brand equity, loyalty, generate revenue, and drive valuation.

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 the 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;

Although there can be no assurance, 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 the following:

Executing existing construction contracts, and

leasing heavy construction equipment.

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Life Sciences segment

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).

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).

There is a growing awareness around PMS, dysmenorrhea, and menopause.

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).

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

In Fiscal 2023, 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.

Two customers accounted for over 10% of sales.

Infrastructure segment

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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.

We also lease our small fleet of heavy construction equipment, including graders, 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.

We currently have one customer and one 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.

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

Business Seasonality

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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.

We face competition from well-funded pharmaceutical companies.

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.

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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.

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

Infrastructure segment:

1 unchanged sentence

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.

Despite the passage of the 2018 Farm Bill, the FDA has not established guidance or rules on the infusion of hemp-based derivatives 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.

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

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

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knowledge of research and development in the field;

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;

patents IGC-501, IGC-502, IGC-504, IGC-505, IGC-507, and IGC-514 for treatment of pain, treatment of seizures in humans and veterinary animals, treatment of cachexia and eating disorders in humans and veterinary animals, method and composition for treating seizure disorders, Alzheimer’s Disease and Self Assembly of Naphthalene Diimide Derivatives and Process Thereof, respectively;

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

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Fondo Nacional De Estupefacientes (FNE) Permits.

Purchase and Resale of physical commodities

General business license

Governmental Regulations

we are subject to oversight and regulations, for some or all of our activities, by the following agencies:

In the U.S., we are subject to oversight and regulations, for some or all of our activities, by the following agencies:

SEC, state regulators, NYSE, FTC, and the FDA.

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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 facilities where hemp will be processed.

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

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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 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.

The FDA will not approve the product unless compliance with the current GMP is satisfactory, and the NDA contains data that provides 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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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.

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

The requirement for a REMS can materially affect the potential market and profitability of the drug.

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National Institutes of Health.

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.

Information related to the product, patient population, phase of the investigation, study sites, 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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The ANDA application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the referenced product has expired.

Upon NDA approval of a new chemical entity or NCE, which is a drug that contains no active moiety that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which time the FDA cannot receive any ANDA or 505(b)(2) application seeking approval of a drug that references a version of the NCE drug.

Upon NDA approval of a new chemical entity or NCE, which is a drug that contains no active component that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which time the FDA cannot receive any ANDA or 505(b)(2) application seeking approval of a drug that references a version of the NCE drug.

Certain changes to a drug, such as the addition of a new indication to the package insert, are associated with a three-year period of exclusivity during which the FDA cannot approve an ANDA or 505(b)(2) application that includes the change.

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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.

Environmental, Social, and Governance (ESG) Efforts .

During Fiscal 2023, we distributed $194 thousand worth of hand sanitizers and other wellness products in an effort to expand the Company’s ESG programs.

As of March 31, 2023, we employed a team of approximately 61 full-time employees in our two segments.

8 unchanged sentences

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