About IGC Pharma

IGC Pharma, Inc. operates as a clinical stage biopharmaceutical company. Segments The company operates through two business segments, Infrastructure and Life Sciences. Infrastructure segment The Infrastructure segment involves the execution of construction contracts. Life Sciences segment Biopharmaceutical Since 2014, this part of the company’s 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, the company focuses its research and development efforts, subject to results of future clinical trials, on seeking pharmaceutical solutions that may alleviate neuropsychiatric symptoms, such as agitation, anxiety, and depression associated with dementia in Alzheimer’s disease; and halt the onset, progression, or cure Alzheimer’s disease. The company has 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 Aß plaques. Over the Counter Products The company has 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 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 company’s Phase 1 trial for IGC-AD1 may provide hope for those patients suffering from mild to severe dementia due to Alzheimer’s disease. 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. In 2018, the company 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. IGC-AD1 Clinical Trial Data To the best of the company’s 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 was conducted using the investigational new drug (IND) IGC-AD1. The company received approval to proceed with the Phase 1 clinical trial from the U.S. Food and Drug Administration (FDA) on July 30, 2020. On December 1, 2021, the company 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. 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, the company expects 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: There is no approved medication for agitation associated with dementia in AD, and about 76% of Alzheimer’s Disease (AD) patients suffer from agitation as rated by the Cohen-Mansfield Agitation Inventory (CMAI) (Van der Mussele, et al., 2015). While there can be no guarantee, the company expects 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. NMI Compounds On November 11, 2021, Hamsa Biopharma India Pvt. Ltd. (‘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. Pursuant to the agreement, the company (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 The company is engaged in human trials with IGC-AD1 that targets certain symptoms associated with dementia in Alzheimer’s. IGC-AD1 is 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 The company’s intention is to use its intellectual property (‘IP’) to develop products that the company can bring to market in one or more of the following channels: Pharmaceutical products that are subject to FDA-approvals. The company has one Alzheimer’s symptom modifying investigational drug candidate (IGC-AD1) in Phase 2 clinical trials under an INDA (Investigational New Drug Application) 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 the company’s IP to market. The company holds all rights to the patents that it filed with the United States Patent and Trademark Office. In 2017, the company also acquired exclusive rights to the data and the patent filing from the University of South Florida. Subsequent to Fiscal 2022 (year ended March 31, 2022), the company acquired exclusive rights to the data and the patent filing from the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR). Products and Services In 2022, the company created and began marketing two brands, Holief and Sunday Seltzer, in accordance with applicable laws and regulations. Holief In 2022, the company 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 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 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 segment includes: Execution of Construction Contracts – The company is executing a road-building contract in Kerala, India and was recently awarded another road reconstruction project; and Rental of Heavy Construction Equipment – The company rents equipment, such as a motor grader and rollers, to construction contractors. Business Strategy 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. 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. The company’s 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. 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. The company hopes to leverage its R&D and intellectual property to develop ground-breaking, science-based products that are proven effective through clinical trials, subject to FDA approval. This strategy can improve the company’s existing products and lead to the creation of new hemp-based products that can provide treatment options for multiple conditions, symptoms, and side effects. The company’s 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 The U.S. sales of cannabis and hemp-derived CBD products are expected to increase in all channels—dispensary, general retail, and pharmaceutical. With diversified CBD-based brands in multiple markets, including infused seltzer (Sunday Seltzer) and pain relief (Holief), the company is well positioned to take advantage of these market trends. Infrastructure segment In 2022, the company’s Infrastructure business focused on projects in the state of Kerala. While executing this construction project, the company took the advantage of other opportunities to generate revenue from its infrastructure assets. The company also leases its small fleet of heavy construction equipment, including grader, rollers etc. to construction companies. The company has 1 customer and 1 subcontractor/supplier of infrastructure materials. Business Seasonality 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. Governmental Regulations In the U.S., the company is subject to oversight and regulations, for some or all of its activities, by the following agencies: the Securities and Exchange Commission, state regulators, NYSE, FTC, and the FDA. Research and Development The company’s research and development expenses were attributed to its Life Sciences segment. The research and development expenses were $2.3 million in the year ended March 31, 2022. History The company, a Maryland corporation, was founded in 2005. It was incorporated in 2005. The company was formerly known as India Globalization Capital, Inc. and changed its name to IGC Pharma, Inc. in March 2023.