Full Press Release Details
POTOMAC, Maryland – August 11 , 2026 – IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”) , a clinical-stage biotechnology company developing treatments for Alzheimer’s disease, today announced that it is strengthening its regulatory, biostatistical, artificial intelligence (“AI”)-enabled data science, and strategic pharmaceutical development capabilities as IGC-AD1, the Company’s lead Alzheimer’s drug candidate, advances toward expected Phase 2 topline results in the fourth quarter of 2026.
CALMA has randomized 160 participants to date. IGC Pharma expects to close enrollment after up to eight additional randomizations, marking a key final enrollment milestone before patient follow-up, database lock, unblinding, and topline analysis. This final planned over-enrollment phase is intended to strengthen the dataset for end-of-treatment, secondary, and exploratory analyses.
The Company is strengthening these capabilities to support clinical data review, AI-assisted data quality activities, regulatory preparedness for potential engagement with the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”), and strategic evaluation by potential pharmaceutical partners following completion of the Phase 2 CALMA trial. As part of this readiness effort, IGC Pharma has engaged OPIS Research, a full-service global contract research organization founded in Italy, to support EMA-related regulatory interactions.
“CALMA is moving through its final enrollment phase, and our focus is now on execution, data quality, and readiness for the next set of milestones,” said Ram Mukunda, Chief Executive Officer of IGC Pharma. “With 1 60 participants randomized and up to eight additional randomizations expected before enrollment closure, we are preparing the CALMA dataset for rigorous scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial. If supported by the CALMA results, we believe these activities could support a more efficient transition from clinical execution to data analysis, regulatory planning, and potential next-stage development.”
IGC-AD1 is IGC Pharma’s lead investigational therapeutic candidate for agitation associated with Alzheimer’s dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.
As CALMA approaches enrollment closure and expected topline readout in the fourth quarter of 2026, IGC Pharma continues advancing both its Alzheimer’s therapeutic pipeline and AI-enabled development capabilities in preparation for one of the Company’s most significant clinical milestones to date.
About IGC Pharma
IGC Pharma, Inc . (NYSE American: IGC) is a clinical-stage biotechnology company developing therapeutics for Alzheimer’s disease and other indications. The Company’s lead asset, IGC-AD1, is being evaluated in the Phase 2 CALMA clinical trial for agitation associated with Alzheimer’s dementia. The Company is also developing AI-enabled tools intended to support biomedical discovery, data harmonization, and clinical development. Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the development, capabilities, performance, testing results, demonstration, deployment, potential utility, commercialization, and future applications of AHA; expansion into additional data modalities, including imaging and omics; planned activities at AAIC 2026 and any relationship with the Alzheimer’s Disease Data Initiative or AD Workbench ecosystem; potential collaborations, licensing, partnerships, and disease-specific deployment opportunities; and the Company’s clinical development programs, including IGC-AD1 and the CALMA trial. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to software development, internal and external testing results and their reproducibility, validation, third-party and ecosystem adoption, data access and rights, intellectual property protection, regulatory considerations, commercialization, clinical trial timelines and outcomes, financing needs, 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. The Company undertakes no obligation to update these statements except as required by law.