India Globalization Capital, Inc. also known as IGC (NYSE: IGC) reported its third fiscal quarter 2023 financial results. Revenue increased 133% to $332,000 in the quarter ending Dec. 31, 2022, versus last year’s $142,000 in the same time period. The company attributed the increase to its life science segment, which includes, among others, natural products targeting women with premenstrual syndrome (“PMS”), period pain, and sleep disorder. The net loss for the quarter was approximately $2.2 million or ($0.04) per share, compared to approximately $2.4 million or ($0.05) per share for last year.
Ram Mukunda, CEO of IGC, commented, “We are delighted with the progress made during this quarter, highlighted by the commencement of Phase 2 clinical trial for our drug candidate IGC-AD1 for the safety and efficacy of the drug on agitation in dementia due to Alzheimer’s disease. This represents a milestone in our progress towards gaining FDA approval for IGC-AD1, which we believe has the potential to revolutionize the treatment of Alzheimer’s disease as the first and only low-dose, natural, THC-based candidate currently undergoing FDA trials. Moreover, our sales of natural products, which include gummies and pain relief creams, are seeing increased traction in the market. We’re encouraged by our third quarter results and look forward to driving continued expansion through the balance of fiscal 2023.”
Selling, general and administrative expenses in the quarter were approximately $1.5 million which dropped from last year’s $2.07 million. IGC attributed the decrease of $496,000 to a reduction in compensation, legal and marketing expenses.
IGC noted that it expanded the number of sites participating in its Phase 2 clinical trial on IGC-AD1 for agitation in dementia from Alzheimer’s disease to a total of four – three in the U. S. and one in Canada. The company said has decided to increase the number of trial sites to between 10 and 12 from the originally planned four to five.
The company posted the following update on the study:
The trial will enroll 146 patients, with one half receiving a placebo and the other half receiving IGC-AD1. The goal of the trial is to evaluate and establish, over six weeks, the efficacy of IGC-AD1 in treating agitation in dementia from Alzheimer’s disease. Agitation affects about 76% of individuals with Alzheimer’s (Mussele et al., 2015), which affects about 11 million individuals in North America and Europe alone. In addition, agitation is a leading cause of hospitalization and a major factor in accelerating the cognitive decline of patients with Alzheimer’s (Kongpakwattana et al., 2018). Currently, there is no FDA-approved medication for treating agitation in Alzheimer’s. The company is positioning itself to offer the first natural tetrahydrocannabinol based medication for treating agitation in dementia from Alzheimer’s disease. The trial is registered on clinicaltrials.gov with NCT05543681.
IGC has two investigational drug assets targeting Alzheimer’s disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating key hallmarks of Alzheimer’s disease such as plaques or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol based formulation that is currently in a 146-person Phase 2B safety and efficacy clinical trial for agitation in dementia due to Alzheimer’s (clinicaltrials.gov, NCT05543681). The company also markets two wellness brands, Holief and Sunday Seltzer. Holief targets women experiencing premenstrual syndrome and menstrual cramps, and Sunday Seltzer is a lifestyle, hemp-infused energy beverage brand.