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About IGC Pharma Inc.
IGC Pharma Inc. (NYSE American: IGC) is a clinical-stage biotechnology company at the forefront of developing innovative, cannabinoid-based therapies for complex medical conditions, including Alzheimer's disease, chronic pain, and other neurological and oncological disorders. Leveraging advanced artificial intelligence (AI) and deep learning technologies, IGC Pharma is pioneering treatments that address critical unmet medical needs while transforming patient care with fast-acting, safe, and effective solutions.
Core Pharmaceutical Innovations
IGC Pharma's flagship therapeutic candidate, IGC-AD1, is a cannabinoid-based formulation currently undergoing Phase 2 clinical trials to treat agitation in dementia associated with Alzheimer's disease. This investigational drug targets key Alzheimer's disease hallmarks such as amyloid plaques, tau tangles, and neuroinflammation, offering a dual-action mechanism that sets it apart from traditional medications. IGC-AD1 has demonstrated potential for faster-acting and more effective relief in interim data, positioning it as a promising candidate in Alzheimer's treatment. Additionally, the company is advancing its TGR family of compounds, including TGR-63, which has shown the ability to cross the blood-brain barrier and target amyloid plaques, a hallmark of Alzheimer's pathology.
AI-Driven Research and Development
IGC Pharma integrates cutting-edge AI technologies into its drug discovery processes. Its AI models are designed to predict potential biomarkers for early Alzheimer's detection, optimize clinical trials, and enhance receptor affinity predictions. This innovative approach not only accelerates the drug development timeline but also ensures precision in targeting complex disease pathways. The company's AI-driven initiatives have garnered recognition, including awards from the National Institute on Aging's PREPARE Challenge for advancements in early Alzheimer's prediction.
Expansion into the Wellness Market
Complementing its pharmaceutical endeavors, IGC Pharma operates Holiby™, a wellness brand offering scientifically formulated products targeting immunity, energy, and anti-aging. The brand's product lines, such as Immunity Gummies and Longevity Gummies, are designed to meet the growing consumer demand for natural, effective health solutions. By leveraging its state-of-the-art manufacturing facilities, originally established for pharmaceutical production, IGC Pharma creates operational efficiencies while generating near-term revenue through direct-to-consumer sales, white-label partnerships, and digital marketing strategies.
Strategic Positioning and Industry Impact
Operating at the intersection of biotechnology, AI, and wellness, IGC Pharma is uniquely positioned to address both immediate consumer health needs and long-term therapeutic challenges. With 32 patent filings and a robust clinical pipeline, the company demonstrates a strong commitment to innovation and patient care. Its dual focus on pharmaceuticals and wellness products not only diversifies its revenue streams but also enhances its resilience in a competitive market landscape.
Commitment to Innovation and Patient Care
IGC Pharma's mission extends beyond drug development to improving the quality of life for patients and caregivers. By addressing critical conditions such as Alzheimer's-related agitation and advancing early detection methods, the company aims to alleviate the emotional and economic burdens associated with these diseases. Its holistic approach, combining pharmaceutical innovation with wellness solutions, underscores a commitment to transforming healthcare outcomes.
India Globalization Capital (IGC) has completed its Phase 1 clinical trial of IGC-AD1, a cannabis-based investigational drug for Alzheimer’s disease. The trial involved 12 participants, primarily elderly individuals with mild to moderate Alzheimer’s. Results indicate that IGC-AD1 was safe and well-tolerated. Secondary endpoints have also been completed, but results are yet to be disclosed. IGC plans to seek FDA concurrence on these findings and aims for future trials to support potential relief for the projected 50 million Alzheimer’s patients worldwide by 2030.
India Globalization Capital, Inc. (IGC) reported financial results for Q2 2021, revealing revenues of approximately $77,000, down from $584,000 in Q2 2020. The decline is attributed to COVID-19's impact, particularly in its Infrastructure segment. Notably, IGC received a patent for its Alzheimer’s treatment, IGC-AD1, and completed its Phase 1 clinical trial. R&D expenses rose to about $444,000 due to the trial, while the company recorded a net loss of $1.8 million, slightly improved from $1.9 million a year earlier. Liquidity remains adequate for upcoming efficacy trials.
India Globalization Capital (IGC) announced the issuance of a patent (#11,065,225) by the USPTO for the treatment of Alzheimer’s disease using an ultra-low dose of THC. The patent stems from research initiated by the University of South Florida and was licensed exclusively to IGC in 2017. IGC's proprietary formulation, IGC-AD1, is currently undergoing Phase 1 clinical trials to assess its safety and tolerability. The release also highlights potential risks and uncertainties related to commercialization and FDA approval.
India Globalization Capital (IGC) has successfully completed Cohort 3 of its Phase 1 clinical trial for IGC-AD1, a THC-based drug targeting Alzheimer’s disease. FDA approval was granted on July 30, 2020, for trials involving patients suffering from mild to severe Alzheimer's. The trial monitored various adverse events, including somnolence and hypotension, while emphasizing the potential relief for the 50 million people affected by Alzheimer’s by 2030. IGC aims to report findings from all cohorts to the FDA following the Data and Safety Monitoring Committee’s review.
India Globalization Capital (IGC) reported a revenue decline to approximately $898,000 for Fiscal 2021, down from $4.1 million in Fiscal 2020, primarily due to the COVID-19 pandemic. The company's revenue was largely derived from its Life Sciences segment, which included sales of hand sanitizers. The net loss for Fiscal 2021 increased to $8.8 million or $0.21 per share, compared to $7.3 million or $0.19 per share in Fiscal 2020, driven by higher SG&A expenses. The company remains focused on ongoing Phase 1 trials for its THC-based drug targeting Alzheimer's disease, amidst anticipated market volatility.
India Globalization Capital, Inc. (IGC) has completed Cohort 2 of its Phase 1 clinical trial for IGC-AD1, a THC-based drug aimed at alleviating Alzheimer’s symptoms. The trial, approved by the FDA in July 2020, included an increase in dosage from one to two doses per day. The Data and Safety Monitoring Committee has recommended advancing to Cohort 3, where participants will receive three doses daily. The trial aims to assess safety and behavioral changes, concluding between July and September 2021, with potential future trials for efficacy depending on results.
India Globalization Capital (NYSE American: IGC) announced receiving patent #10,933,082 from the USPTO on March 2, 2021. This patent covers a cannabinoid composition and method for treating pain associated with Psoriatic Arthritis, Fibromyalgia, Scleroderma, and other conditions. The application was submitted on October 1, 2018. This approval enhances IGC's existing patent portfolio, which already includes patents for seizure and eating disorders.
India Globalization Capital (IGC) has initiated its phase 1 clinical trial for IGC-AD1, a THC-based investigational drug for Alzheimer's disease, approved by the FDA on July 30, 2020. The first dosing level has been administered to five of twelve patients, with ongoing enrollment. The trial aims to assess pharmacokinetics of THC and its interaction with the CYP2C9 gene, which is crucial for metabolizing THC and various medications. CEO Ram Mukunda highlighted that while no cure for Alzheimer's exists, THC may improve patient quality of life.
India Globalization Capital (IGC) reported financial results for Q3 2021, revealing a significant revenue decline to $108 thousand from $573 thousand in Q3 2020, primarily due to COVID-19 restrictions. Revenue was 15% from infrastructure and 85% from Life Sciences. The company faced increased expenses, with SG&A rising 55% to $2,186 thousand, largely driven by overheads, marketing, and a SEC settlement. The net comprehensive loss for the quarter was $2,283 thousand or $0.06 per share, compared to $1,646 thousand or $0.04 per share from the prior year.
India Globalization Capital (NYSE AMERICAN: IGC) held its Annual Meeting of Shareholders on January 11, 2021, where all voting matters disclosed in the Definitive Proxy were approved. Key outcomes included the election of John E. Lynch to the Board of Directors, ratification of Manohar Chowdhry & Associates as auditors for FY 2021, and approval to grant up to 2,500,000 shares to employees and advisors based on performance metrics. Additionally, the frequency of 'say-on-pay' votes was set to every three years.
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