NOTE 1 – BUSINESS DESCRIPTION

Business

IGC has two segments: Infrastructure and Life Sciences. The Company’s Infrastructure Business, managed from India, involves: (a) the execution of construction contracts, (b) the purchase and resale of physical commodities used in infrastructure, and (c) the rental of heavy construction equipment. The Company’s revenue for the six months ended September 30, 2019 was primarily derived from this segment.

The Company’s Life Sciences segment, managed from the United States (“U.S.”), involves: (a) the development of potential new drugs, subject to applicable regulatory approvals, (b) several hemp-based and non-hemp-based products and brands in various stages of development, for sale online and through stores, including tinctures, creams for pain relief, a beverage, and hand sanitizers, among others, (c) wholesale of hemp extracts including hemp crude extract and hemp isolate, among others, (d) hemp growing and processing facilities, (e) white labeling of hemp-based products and (f) the offering of tolling services like extraction and distillation to hemp farmers. The Company’s revenue for the six months ended September 30, 2020 was primarily derived from this segment.

The Company’s principal office is located in the U.S. in Maryland. Additionally, the Company has a facility in Washington and offices in Colombia, Hong Kong, and India.

Business updates

The current SARS-CoV-2 (“COVID-19”) pandemic and its impact on certain aspects of the economy has severely impacted our revenue and increased our expenses. In the past 6 months, our ability to provide services and distribute our products has been impacted due to store closures and abandoned harvests of hemp. Our facility on the West Coast and our Delhi office have had COVID-19 outbreaks that have led to closures, delays and expenses.

In response, we began decreasing our staff, delayed and may ultimately terminate the Evolve I, Inc. acquisition, and have reoriented our sales focus to online. In addition, we have begun our Phase 1 human trial on IGC-AD1. IGC remains committed to its Infrastructure business line and intends to continue pursuing the execution of construction contracts, the purchase and resale of physical commodities used in infrastructure, and the rental of heavy construction equipment as the COVID-19 pandemic allows.

Investigational Drug Candidate (“IDC”), IGC-AD1:

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Subsequent to September 30, 2020, the Company received an approval from the Institutional Review Board (“IRB”), engaged a Principal Investigator, engaged a study site, and began enrolling participants for a Phase 1 trial on its IDC.

Background: As previously reported, on July 30, 2020, IGC received notice from the FDA to proceed with a 12-subject Phase 1 human clinical trial (“removal of full clinical hold”) on its Investigational New Drug Application (“INDA”), IGC-AD1, submitted under Section 505(i) of the Federal Food, Drug, and Cosmetic Act. In order to get an investigational drug approved as a pharmaceutical drug, the Sponsor, in this case IGC Pharma, LLC, a subsidiary of IGC, must conduct several trials and gather data. These typically start with pre-clinical trials that involve testing the IDC on cells outside of a living organism (in vitro), followed by animal testing. In our case, the in vitro data along with animal data was previously disclosed.

Based on promising evidence, we decided to pursue human trials for which the FDA must give permission before the IDC can be tested on humans. In 2018, we began the process of submitting an Investigational New Drug Application (INDA) to the FDA. This involves presenting among others, the results of in vitro and animal studies, safety data, the protocol outlining how a potential trial will be run, how data will be collected, how patient data will be protected, how the IDC will be made, who will make it, what is in it, how stable the IDC is, as well as details on the Chemistry, Manufacturing and Controls (CMC) that will be followed. In addition, we committed to getting an Informed Consent Form (ICF) from participants, that the ICF would be reviewed and approved by an IRB, and that the Sponsor will follow all the rules required for studying IDCs, including those surrounding COVID-19.

There are several stages, or phases, of trials that build on previous phases. Phase zero, not a requirement, is typically in small doses to small groups to gather anecdotal evidence of efficacy and safety. We gathered anecdotal unscientific evidence mostly to ascertain safety and get feedback from patients through 2018 and 2019. Phase 1 studies are conducted to find the highest dose that a patient can tolerate without severe side effects. Phase 2 clinical trials are conducted to ascertain if the IDC has the expected efficacy, that is it does what is expected, and phase 3 studies are conducted to measure responses against existing drugs or treatments.

Our Phase 1 study is a placebo-controlled study. IGC-AD1 will be administered for three 14-day periods with the dose escalated in each period. The participants will be monitored daily, certain data will be collected, and while safety is the main concern, we will also, for research purposes, collect data beyond safety. For example, we expect to collect data on how fast the IDC is absorbed through the body, how long it lasts, and whether different individuals process it differently (polymorphisms of P4502C9 on pharmacokinetics). In addition, we will monitor certain behavioral aspects of the patient that can help us in the next phases of the study. The patients that we sign up for the study are individuals suffering from mild to severe dementia due to Alzheimer’s disease.

Other updates:

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On July 17, 2020, the Company filed a provisional patent application with the USPTO for its IGC-511 formulation for a Cannabidiol based composition and method for treating pain.

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On August 5, 2020, the USPTO issued the Company a patent (#10751300) for the Company’s cannabinoid formulation (IGC-502) for the treatment of seizures in humans and veterinary animals.

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The Company is executing a road building contract in Kerala, India valued at approximately $1.2 million. The Company estimates that it will take between 12 and 15 months to complete the work. Work on this project had been temporarily delayed due to COVID-19 and was partially resumed during the three months ended September 30, 2020.

Business Organization

As of September 30, 2020, the Company had the following direct operating subsidiaries: Techni Bharathi Private Limited (“TBL”), IGCare, LLC (“IGCare"), Holi Hemp, LLC (“Holi Hemp”), IGC Pharma, LLC (“IGC Pharma”), SAN Holdings, LLC (“SAN Holdings”), Sunday Seltzer, LLC (“Sunday Seltzer”) and Colombia-based beneficially owned subsidiary Hamsa Biochem SAS (“Hamsa”). The Company’s fiscal year is the 52- or 53-week period that ends on March 31. The Company is a Maryland corporation established in 2005. The Company’s filings are available on www.sec.gov.