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IGC Pharma Reports First Quarter Fiscal 2026 Financial Results; Company Accelerates Phase 2 Alzheimer's Trial
POTOMAC, Md., August 19, 2025 (Newswire.com) - IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, reported its financial results for the quarter ended June 30, 2025. Highlights in the quarter include: * Accelerated progress on the Company's Phase 2 CALMA trial in Alzheimer's disease * Progress in the development of MINT-AD * Extension of its undrawn $12M credit facility Ram Mukunda, CEO of IGC Pharma, commented, "We began fiscal 2026 with solid strategic momentum, advancing multiple programs that we believe position IGC for meaningful value creation this fiscal year. Our Phase 2 CALMA trial for IGC-AD1, a cannabinoid-based proprietary formulation with the potential to address agitation, a debilitating symptom affecting up to 76% of Alzheimer's patients, continues to progress toward critical milestones in the FDA clinical trial process. In parallel, our non-cannabinoid platforms, TGR-63 and IGC-M3, are moving through preclinical development with the goal of addressing underlying disease modification. We also made progress with MINT-AD, by increasing the number of harmonized databases and training algorithms. MINT-AD is our first-of-its-kind AI-driven physician's tool to help identify and stratify Alzheimer's risk factors and predict cognitive decline, which we believe can help the over 400 million individuals with early Alzheimer's pathology who are at risk for Alzheimer's." Q1 FY2026 Company's Highlights: Strategic & Operational Highlights * The Company is moving aggressively to cut cost and shift more resources to completing the CALMA Phase 2 trail and completing implementing MINT-AD. During, and subsequent to the end of the quarter IGC Pharma raised approximately $3.5 million via private placements and at-the-market (ATM) offering. Company Updates: * On July 21, 2025, IGC's Principal Scientist Dr. Jagadeesh Rao received a Best Researcher Award at the 11th Annual World Neuroscience Awards. * Between July 29 and 30, 2025, the Company presented multiple posters at the Alzheimer's Association International Conference (AAIC) in Toronto, an event attended by approximately 10,000 participants. Presentations included new data on MINT-AD, IGC's flagship AI model for the early detection of Alzheimer's disease. Financial Summary * The net loss for the three months ended June 30, 2025, was approximately $1.6 million or $0.02 per share, compared to approximately $2.3 million or $0.03 per share for the three months ended June 30, 2024. As of June 30, 2025, the Company has not drawn on the $12 million available under the Credit Agreement with O-Bank. IGC Pharma's financial statements for the quarter ended June 30, 2025, filed on Form 10-Q, are available on www.sec.gov. About IGC Pharma (dba IGC): IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 30 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Contact Information Rosalyn Christian / John Nesbett IMS Investor Relations [email protected] (203) 972-9200
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IGC Pharma : Letter to Stockholders FYE2025 Annual Report
Fiscal 2025 was a transformative year for IGC Pharma as we advanced on two synergistic fronts: developing a potential safe and effective therapy for agitation in Alzheimer's, IGC-AD1, and building MINT-AD, an AI-powered diagnostic platform designed to identify at-risk individuals before cognitive decline becomes irreversible. Together, these initiatives form a novel, complementary approach to Alzheimer's-one that aims to shift the standard of care from reactive to proactive. IGC-AD1: Clinical Momentum and Expanding Potential One of our most significant milestones this year was the interim data from our Phase 2 CALMA trial, evaluating IGC-AD1 for treating agitation in Alzheimer's disease-a debilitating symptom affecting approximately 76% of patients and currently addressed by only one FDA-approved drug. On April 2, 2024, we announced that IGC-AD1 met its primary interim endpoint, demonstrating a clinically and statistically significant reduction in agitation by Week 6, with effects emerging as early as Week 2. Alzheimer's pathology. Our presentation of genetic toxicology safety data in May 2025 further supports IGC-AD1's profile as a candidate for long-term, broad-based intervention in this vulnerable population. We have also broadened the CALMA trial network across North America, adding sites in Ontario, Florida, Rhode Island, Puerto Rico, and Oklahoma to accelerate recruitment and enhance the diversity and robustness of our clinical data. MINT-AD: Building the Future of Early Detection Parallel to our therapeutic progress, we advanced MINT-AD, our scalable multimodal AI diagnostic platform designed to detect Alzheimer's disease before symptoms emerge. Trained on over 100 harmonized global datasets, including cognitive scores, genomic markers, neuroimaging, lifestyle factors, and digital biomarkers, MINT-AD is being developed as a foundation model for clinical decision support, with the goal of enabling earlier intervention for at-risk individuals. Imagine a general practitioner in a rural clinic, without access to advanced imaging tools. MINT-AD can provide a personalized risk profile using available patient data, helping that doctor flag Alzheimer's risk 2-5 years before clinical decline, and refer the patient for early care. This is the type of accessible intelligence that could transform the care trajectory for millions. In recognition of our innovation, IGC Pharma was honored with two national awards in the PREPARE Challenge (Pioneering Research for Early Prediction of Alzheimer's), affirming our leadership in AI-driven Alzheimer's diagnostics. Operational Discipline and Financial Focus In Fiscal 2025, we demonstrated a firm commitment to operational efficiency and financial discipline: Looking ahead, we are targeting an additional 10% to 15% reduction in operating expenses in FY2026 through strategic realignment, AI integration, and management accountability. Together, these efforts reinforce our mission to deliver real-world impact for patients and caregivers while driving long-term value for our shareholders. Thank you for your continued trust and support as we advance toward a future where
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IGC Pharma reports progress in AI-powered Alzheimer's diagnostics and treatment, showcasing advancements in their Phase 2 CALMA trial and MINT-AD AI platform.
IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage biotechnology company, has reported its financial results for the first quarter of fiscal year 2026, ended June 30, 2025. The company, which leverages artificial intelligence to develop innovative treatments for Alzheimer's disease, has made significant strides in both its clinical trials and AI-driven diagnostic platform 1.
IGC Pharma's primary focus remains on its Phase 2 CALMA trial, which is evaluating IGC-AD1, a cannabinoid-based proprietary formulation designed to address agitation in Alzheimer's patients. The company reports accelerated progress in this trial, which targets a symptom affecting up to 76% of Alzheimer's patients 1.
In parallel, IGC Pharma is advancing its non-cannabinoid platforms, TGR-63 and IGC-M3, through preclinical development. These platforms aim to address underlying disease modification in Alzheimer's, potentially offering a more comprehensive approach to treatment 1.
A key highlight of IGC Pharma's recent developments is the progress made with MINT-AD, their AI-driven physician's tool. MINT-AD is designed to identify and stratify Alzheimer's risk factors and predict cognitive decline. The company has increased the number of harmonized databases and improved its training algorithms, enhancing the tool's capabilities 1.
MINT-AD represents a significant step forward in early Alzheimer's detection. Trained on over 100 harmonized global datasets, including cognitive scores, genomic markers, neuroimaging, and lifestyle factors, MINT-AD aims to detect Alzheimer's disease before symptoms emerge. This could potentially benefit over 400 million individuals with early Alzheimer's pathology who are at risk for the disease 2.
For the quarter ended June 30, 2025, IGC Pharma reported a net loss of approximately $1.6 million or $0.02 per share, an improvement from the $2.3 million or $0.03 per share loss in the same period of the previous year. The company has also raised approximately $3.5 million through private placements and at-the-market offerings 1.
IGC Pharma is implementing cost-cutting measures and reallocating resources to prioritize the completion of the CALMA Phase 2 trial and the implementation of MINT-AD. The company maintains an undrawn $12 million credit facility with O-Bank, providing additional financial flexibility 1.
IGC Pharma's innovative approach to Alzheimer's research has garnered recognition in the scientific community. The company's Principal Scientist, Dr. Jagadeesh Rao, received a Best Researcher Award at the 11th Annual World Neuroscience Awards. Additionally, IGC Pharma presented multiple posters at the Alzheimer's Association International Conference in Toronto, showcasing new data on MINT-AD 1.
Looking ahead, IGC Pharma aims to further reduce operating expenses by 10% to 15% in FY2026 through strategic realignment, AI integration, and management accountability. The company remains committed to delivering real-world impact for patients and caregivers while driving long-term value for shareholders 2.
As IGC Pharma continues to advance its AI-driven approach to Alzheimer's diagnosis and treatment, it represents a notable example of how artificial intelligence is being leveraged to address complex health challenges and potentially transform patient care in the field of neurodegenerative diseases.
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