Full Press Release Details
CALMA randomized 170 participants; topline results expected following last patient- last dose, database lock and unblinding
POTOMAC, MD / ACCESS Newswire / November 9, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company"), a clinical-stage biotechnology company developing investigational therapies and AI-enabled tools for Alzheimer's disease, today reported financial results and business updates for the third quarter ended September 30, 2026.
"CALMA enrolled is complete." said Ram Mukunda, Chief Executive Officer of IGC Pharma. "Once the last participant receives the last dose, we will verify the data using AI, lock the database from further changes, unblind the study, and have external independent statisticians analyze the data to determine the topline results."
CALMA's primary topline objective is to evaluate agitation in Alzheimer's at Week 6. Other analysis include agitation in Alzheimer's at Week 2, the impact of IGC-AD1 on cognition, psychosis, sleep disturbance, caregiver burden, safety, and various blood-based biomarkers.
CALMA is a randomized, double-blind, placebo-controlled trial evaluating IGC-AD1, an investigational oral liquid medication, for agitation in Alzheimer's disease. Agitation is a serious neuropsychiatric condition that can substantially burden caregivers and contribute to earlier assisted-living or nursing-home placement. Agitation in Alzheimer's affects millions of Americans, and the International Psychogeriatric Association (IPA) framework recognizes agitation as a clinically significant syndrome involving emotional distress, excessive motor activity, verbal aggression, or physical aggression, with associated disability.
Full financial statements and management's discussion are available in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, filed with the SEC.
IGC Pharma, Inc. (NYSE American:IGC) is a clinical-stage biotechnology company developing investigational therapies for Alzheimer's disease and AI-enabled technologies supporting drug discovery, clinical research, cognitive risk assessment, and brain-health monitoring. Its lead therapeutic candidate, IGC-AD1, is being evaluated in the Phase 2 CALMA clinical trial for agitation in Alzheimer's dementia. The Company's AI portfolio includes MINT-AD TM , PRISM by IGC Pharma TM , and aha TM , its Agentic Harmonization Assistant, which are all being developed to support clinical-decision-making, patient monitoring, and commercial healthcare applications.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Phase 2 CALMA trial evaluating IGC-AD1 for agitation in Alzheimer's dementia; the timing of database lock, unblinding, topline analysis, and reporting of results; potential further clinical development and regulatory submissions; PRISM, MINT-AD, and aha; the Company's patent protection and partnering plans; and the Company's financial position and liquidity. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including delays in data collection, verification, and analysis; uncertainties regarding the safety and efficacy of IGC-AD1 and whether CALMA will meet its endpoints; the need for additional clinical trials and regulatory review; financing needs and the availability of capital; risks that issued patents may be challenged, narrowed, or circumvented; and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-KT and Quarterly Reports on Form 10-Q. There can be no assurance regarding the timing or outcome of the CALMA trial, regulatory approval, commercialization, or any pharmaceutical partnership. IGC-AD1 is investigational and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. MINT-AD, PRISM, and aha are investigational AI-enabled platforms and are not approved or cleared as diagnostic products. The Company undertakes no obligation to update forward-looking statements except as required by law.